Trial Outcomes & Findings for 90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers (NCT NCT01990794)
NCT ID: NCT01990794
Last Updated: 2014-10-06
Results Overview
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
Before, during and after cobalt supplementation
Results posted on
2014-10-06
Participant Flow
Participant milestones
| Measure |
Study Volunteers
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
One Month Into Study
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
90-Day Cobalt Supplementation Study to Investigate the Cobalt Body Burden in Ten Healthy Adult Volunteers
Baseline characteristics by cohort
| Measure |
Study Volunteers
n=13 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.
|
|---|---|
|
Age, Continuous
Female Age (n=8)
|
34 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Age, Continuous
Male Age (n=5)
|
33 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
|
Weight
Female weight (n=5)
|
151 pounds (lbs)
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Weight
Male weight (n=5)
|
219 pounds (lbs)
STANDARD_DEVIATION 53 • n=5 Participants
|
PRIMARY outcome
Timeframe: Before, during and after cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Cobalt Whole Blood Concentrations
Day 4/5
|
14.6 µg Co/L
Standard Deviation 8.2
|
7.4 µg Co/L
Standard Deviation 3.6
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 8/9
|
33.9 µg Co/L
Standard Deviation 24.0
|
8.5 µg Co/L
Standard Deviation 6.9
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 14/16
|
29.9 µg Co/L
Standard Deviation 22.0
|
13.8 µg Co/L
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 22/23
|
25.6 µg Co/L
Standard Deviation 17.8
|
18.7 µg Co/L
Standard Deviation 11.3
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 29/30
|
37.1 µg Co/L
Standard Deviation 24.8
|
19.3 µg Co/L
Standard Deviation 7.9
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 43/44
|
35.9 µg Co/L
Standard Deviation 27.1
|
18.5 µg Co/L
Standard Deviation 10.5
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 57/58
|
40.7 µg Co/L
Standard Deviation 28.1
|
20.3 µg Co/L
Standard Deviation 11.1
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 71/72
|
37.1 µg Co/L
Standard Deviation 33.7
|
22.1 µg Co/L
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
Day 88/90
|
53.3 µg Co/L
Standard Deviation 45.3
|
20.4 µg Co/L
Standard Deviation 8.5
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
1 wk post
|
22.2 µg Co/L
Standard Deviation 19.3
|
12.0 µg Co/L
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
2 wk post
|
15.9 µg Co/L
Standard Deviation 13.3
|
8.7 µg Co/L
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
6 wk post
|
9.7 µg Co/L
Standard Deviation 7.9
|
5.6 µg Co/L
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
10 wk post
|
5.9 µg Co/L
Standard Deviation 5.4
|
3.9 µg Co/L
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
|
Cobalt Whole Blood Concentrations
16 wk post
|
1.1 µg Co/L
Standard Deviation 0.7
|
0.7 µg Co/L
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Before, during and after cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Cobalt Serum Concentrations
Day 4/5
|
23.3 µg Co/L
Standard Deviation 12.4
|
11.0 µg Co/L
Standard Deviation 5.7
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 8/9
|
42.3 µg Co/L
Standard Deviation 33.4
|
11.8 µg Co/L
Standard Deviation 9.7
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 14/16
|
42.5 µg Co/L
Standard Deviation 30.9
|
20.4 µg Co/L
Standard Deviation 11.5
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 22/24
|
36.8 µg Co/L
Standard Deviation 24.2
|
34.7 µg Co/L
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 29/30
|
53.9 µg Co/L
Standard Deviation 35.8
|
23.9 µg Co/L
Standard Deviation 8.7
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 43/44
|
48.2 µg Co/L
Standard Deviation 34.5
|
24.3 µg Co/L
Standard Deviation 16.5
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 57/58
|
34.9 µg Co/L
Standard Deviation 20.3
|
24.1 µg Co/L
Standard Deviation 15.7
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 71/72
|
46.1 µg Co/L
Standard Deviation 40.8
|
28.2 µg Co/L
Standard Deviation 18.0
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
Day 88/90
|
71.2 µg Co/L
Standard Deviation 60.0
|
25.2 µg Co/L
Standard Deviation 13.2
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
1 wk post
|
21.9 µg Co/L
Standard Deviation 20.6
|
8.4 µg Co/L
Standard Deviation 3.1
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
2 wk post
|
12.5 µg Co/L
Standard Deviation 11.6
|
4.6 µg Co/L
Standard Deviation 1.6
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
6 wk post
|
3.8 µg Co/L
Standard Deviation 3.3
|
1.4 µg Co/L
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
10 wk post
|
1.9 µg Co/L
Standard Deviation 1.5
|
0.9 µg Co/L
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
|
Cobalt Serum Concentrations
4 month post
|
0.96 µg Co/L
Standard Deviation 0.6
|
0.5 µg Co/L
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteersPopulation: Analysis was carried out on the first 12 participants of the study
The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.
Outcome measures
| Measure |
Albumin-Co Fraction
n=12 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Albumin Bound Cobalt Fraction in Serum
Subject 10
|
94.9 percentage of total blood cobalt
Standard Deviation 3.2
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 1
|
94.5 percentage of total blood cobalt
Standard Deviation 4.9
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 2
|
95.2 percentage of total blood cobalt
Standard Deviation 3.4
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 3
|
96.5 percentage of total blood cobalt
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 4
|
93.2 percentage of total blood cobalt
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 5
|
96.7 percentage of total blood cobalt
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 6
|
95.6 percentage of total blood cobalt
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 7
|
95.8 percentage of total blood cobalt
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 8
|
95.7 percentage of total blood cobalt
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 9
|
98.2 percentage of total blood cobalt
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 11
|
95.9 percentage of total blood cobalt
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
|
Albumin Bound Cobalt Fraction in Serum
Subject 12
|
96.7 percentage of total blood cobalt
Standard Deviation 1.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 weeks and three monthsPopulation: Participants that completed three months of cobalt supplementation
Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and \>8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Al
|
1.79 units on a scale: stimulation index (SI)
Standard Deviation 1.77
|
2.34 units on a scale: stimulation index (SI)
Standard Deviation 3.0
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Co
|
1.05 units on a scale: stimulation index (SI)
Standard Deviation 0.32
|
1.44 units on a scale: stimulation index (SI)
Standard Deviation 0.72
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Cr
|
1.01 units on a scale: stimulation index (SI)
Standard Deviation 0.38
|
1.43 units on a scale: stimulation index (SI)
Standard Deviation 0.46
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Mo
|
1.23 units on a scale: stimulation index (SI)
Standard Deviation 1.21
|
2.31 units on a scale: stimulation index (SI)
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Ni
|
4.21 units on a scale: stimulation index (SI)
Standard Deviation 3.62
|
4.32 units on a scale: stimulation index (SI)
Standard Deviation 3.0
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: V
|
1.63 units on a scale: stimulation index (SI)
Standard Deviation 0.82
|
1.86 units on a scale: stimulation index (SI)
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Zr
|
1.43 units on a scale: stimulation index (SI)
Standard Deviation 0.56
|
1.41 units on a scale: stimulation index (SI)
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
|
Effects on the Immune System
Normalized lymphocyte transformation response: Fe
|
1.47 units on a scale: stimulation index (SI)
Standard Deviation 0.91
|
1.82 units on a scale: stimulation index (SI)
Standard Deviation 1.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
13.1 g/dL
Standard Deviation 0.31
|
14.9 g/dL
Standard Deviation 0.76
|
—
|
—
|
—
|
—
|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
13.5 g/dL
Standard Deviation 0.43
|
14.9 g/dL
Standard Deviation 0.93
|
—
|
—
|
—
|
—
|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
13.3 g/dL
Standard Deviation 0.50
|
14.8 g/dL
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
13.2 g/dL
Standard Deviation 0.37
|
15.1 g/dL
Standard Deviation 0.74
|
—
|
—
|
—
|
—
|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
13.4 g/dL
Standard Deviation 0.75
|
14.9 g/dL
Standard Deviation 0.78
|
—
|
—
|
—
|
—
|
|
Hemoglobin Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
13.1 g/dL
Standard Deviation 0.61
|
15.0 g/dL
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, \~day 45, \~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Audiological Function
250 Hz
|
10.0 dB
Standard Deviation 4.7
|
8.0 dB
Standard Deviation 6.3
|
9.0 dB
Standard Deviation 3.9
|
8.0 dB
Standard Deviation 6.7
|
7.5 dB
Standard Deviation 3.5
|
6.0 dB
Standard Deviation 5.7
|
|
Changes in Audiological Function
1000 Hz
|
9.0 dB
Standard Deviation 3.2
|
7.5 dB
Standard Deviation 2.6
|
6.5 dB
Standard Deviation 4.1
|
5.0 dB
Standard Deviation 4.1
|
6.5 dB
Standard Deviation 4.7
|
7.5 dB
Standard Deviation 4.2
|
|
Changes in Audiological Function
500 Hz
|
10.0 dB
Standard Deviation 4.1
|
6.0 dB
Standard Deviation 6.1
|
8.5 dB
Standard Deviation 4.7
|
7.5 dB
Standard Deviation 6.8
|
6.5 dB
Standard Deviation 4.7
|
5.5 dB
Standard Deviation 5.0
|
|
Changes in Audiological Function
2000 Hz
|
9.0 dB
Standard Deviation 5.7
|
9.5 dB
Standard Deviation 4.4
|
8.5 dB
Standard Deviation 6.7
|
9.5 dB
Standard Deviation 6.0
|
7.0 dB
Standard Deviation 6.8
|
7.5 dB
Standard Deviation 6.3
|
|
Changes in Audiological Function
3000 Hz
|
7.0 dB
Standard Deviation 7.5
|
8.5 dB
Standard Deviation 4.7
|
7.5 dB
Standard Deviation 6.8
|
8.0 dB
Standard Deviation 4.2
|
8.0 dB
Standard Deviation 7.5
|
5.0 dB
Standard Deviation 3.3
|
|
Changes in Audiological Function
4000 Hz
|
10.5 dB
Standard Deviation 9.0
|
6.0 dB
Standard Deviation 5.7
|
9.5 dB
Standard Deviation 10.1
|
6.0 dB
Standard Deviation 5.2
|
8.5 dB
Standard Deviation 10.5
|
7.5 dB
Standard Deviation 5.4
|
|
Changes in Audiological Function
6000 Hz
|
10.0 dB
Standard Deviation 8.5
|
12.0 dB
Standard Deviation 8.9
|
11.0 dB
Standard Deviation 9.1
|
11.0 dB
Standard Deviation 9.9
|
9.0 dB
Standard Deviation 6.9
|
10.0 dB
Standard Deviation 9.7
|
|
Changes in Audiological Function
8000 Hz
|
5.5 dB
Standard Deviation 7.6
|
10.0 dB
Standard Deviation 7.8
|
8.5 dB
Standard Deviation 8.8
|
7.5 dB
Standard Deviation 7.2
|
9.0 dB
Standard Deviation 7.1
|
7.5 dB
Standard Deviation 5.4
|
|
Changes in Audiological Function
12,000 Hz
|
9.5 dB
Standard Deviation 13.0
|
7.5 dB
Standard Deviation 10.1
|
8.5 dB
Standard Deviation 11.8
|
9.0 dB
Standard Deviation 8.1
|
9.5 dB
Standard Deviation 12.4
|
8.0 dB
Standard Deviation 7.9
|
|
Changes in Audiological Function
16,000 Hz
|
24.0 dB
Standard Deviation 21.2
|
25.5 dB
Standard Deviation 24.9
|
21.0 dB
Standard Deviation 22.6
|
25.0 dB
Standard Deviation 24.7
|
22.0 dB
Standard Deviation 20.0
|
24.0 dB
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Cardiac Function
LVID (ed) (cm)
|
4.77 cm
Standard Deviation 0.52
|
4.75 cm
Standard Deviation 0.55
|
4.65 cm
Standard Deviation 0.44
|
—
|
—
|
—
|
|
Changes in Cardiac Function
LVID (es) (cm)
|
3.15 cm
Standard Deviation 0.38
|
2.97 cm
Standard Deviation 0.49
|
2.95 cm
Standard Deviation 0.55
|
—
|
—
|
—
|
|
Changes in Cardiac Function
RVID (ed) (cm)
|
2.08 cm
Standard Deviation 0.46
|
2.02 cm
Standard Deviation 0.38
|
2.16 cm
Standard Deviation 0.35
|
—
|
—
|
—
|
|
Changes in Cardiac Function
Ao Root (ed) (cm)
|
2.99 cm
Standard Deviation 0.38
|
3.03 cm
Standard Deviation 0.45
|
3.01 cm
Standard Deviation 0.44
|
—
|
—
|
—
|
|
Changes in Cardiac Function
IVS (ed) (cm)
|
1.07 cm
Standard Deviation 0.19
|
1.06 cm
Standard Deviation 0.22
|
1.05 cm
Standard Deviation 0.13
|
—
|
—
|
—
|
|
Changes in Cardiac Function
IVS (es) (cm)
|
1.40 cm
Standard Deviation 0.24
|
1.46 cm
Standard Deviation 0.24
|
1.48 cm
Standard Deviation 0.24
|
—
|
—
|
—
|
|
Changes in Cardiac Function
LVPWs (ed) (cm)
|
0.94 cm
Standard Deviation 0.12
|
0.95 cm
Standard Deviation 0.11
|
0.99 cm
Standard Deviation 0.13
|
—
|
—
|
—
|
|
Changes in Cardiac Function
LVPWs (es) (cm)
|
1.49 cm
Standard Deviation 0.19
|
1.47 cm
Standard Deviation 0.18
|
1.52 cm
Standard Deviation 0.15
|
—
|
—
|
—
|
|
Changes in Cardiac Function
LA (es) (cm)
|
3.15 cm
Standard Deviation 0.21
|
3.34 cm
Standard Deviation 0.34
|
3.13 cm
Standard Deviation 0.44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function
Rim area (mm^2)
|
1.29 mm^2
Standard Deviation 0.23
|
1.35 mm^2
Standard Deviation 0.23
|
1.38 mm^2
Standard Deviation 0.23
|
1.39 mm^2
Standard Deviation 0.29
|
1.31 mm^2
Standard Deviation 0.19
|
1.36 mm^2
Standard Deviation 0.25
|
|
Changes in Visual Function
Disc Area (mm^2)
|
1.65 mm^2
Standard Deviation 0.30
|
1.73 mm^2
Standard Deviation 0.31
|
1.71 mm^2
Standard Deviation 0.33
|
1.74 mm^2
Standard Deviation 0.42
|
1.59 mm^2
Standard Deviation 0.20
|
1.63 mm^2
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90, and \~4-6 post-weeks).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Neurological Function (Peroneal Motor Amplitude)
|
5.1 Peroneal Motor Amplitude (mV)
Standard Deviation 2.3
|
5.5 Peroneal Motor Amplitude (mV)
Standard Deviation 2.3
|
5.6 Peroneal Motor Amplitude (mV)
Standard Deviation 3.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
Baseline (n = 5, 5)
|
6.46 thousand cells/µL
Standard Deviation 0.94
|
6.79 thousand cells/µL
Standard Deviation 1.12
|
—
|
—
|
—
|
—
|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
Days 29 and 30 (n = 5, 5)
|
6.44 thousand cells/µL
Standard Deviation 1.09
|
6.42 thousand cells/µL
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
Days 57 and 58 (n = 5, 5)
|
6.36 thousand cells/µL
Standard Deviation 0.88
|
6.94 thousand cells/µL
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
Days 88 and 90 (n = 5, 5)
|
5.98 thousand cells/µL
Standard Deviation 1.24
|
6.34 thousand cells/µL
Standard Deviation 0.75
|
—
|
—
|
—
|
—
|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
1 wk postdose (n = 5, 5)
|
6.1 thousand cells/µL
Standard Deviation 1.51
|
7.1 thousand cells/µL
Standard Deviation 1.78
|
—
|
—
|
—
|
—
|
|
White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation
2 wk postdose (n = 5, 5)
|
6.34 thousand cells/µL
Standard Deviation 0.92
|
6.42 thousand cells/µL
Standard Deviation 0.46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
4.42 million cells/µL
Standard Deviation 0.28
|
4.71 million cells/µL
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
4.28 million cells/µL
Standard Deviation 0.18
|
4.70 million cells/µL
Standard Deviation 0.20
|
—
|
—
|
—
|
—
|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
4.3 million cells/µL
Standard Deviation 0.21
|
4.81 million cells/µL
Standard Deviation 0.18
|
—
|
—
|
—
|
—
|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
4.32 million cells/µL
Standard Deviation 0.27
|
4.72 million cells/µL
Standard Deviation 0.32
|
—
|
—
|
—
|
—
|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
4.42 million cells/µL
Standard Deviation 0.37
|
4.77 million cells/µL
Standard Deviation 0.24
|
—
|
—
|
—
|
—
|
|
Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
4.38 million cells/µL
Standard Deviation 0.31
|
4.79 million cells/µL
Standard Deviation 0.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
41.5 Percentage
Standard Deviation 1.68
|
45.1 Percentage
Standard Deviation 2.53
|
—
|
—
|
—
|
—
|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
40.9 Percentage
Standard Deviation 1.15
|
45.0 Percentage
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
41.0 Percentage
Standard Deviation 1.14
|
46.3 Percentage
Standard Deviation 2.75
|
—
|
—
|
—
|
—
|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
40.9 Percentage
Standard Deviation 2.00
|
45.0 Percentage
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
41.7 Percentage
Standard Deviation 2.17
|
45.8 Percentage
Standard Deviation 2.39
|
—
|
—
|
—
|
—
|
|
Hematocrit Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
40.9 Percentage
Standard Deviation 2.42
|
45.7 Percentage
Standard Deviation 1.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Protein Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
7.08 g/dL
Standard Deviation 0.28
|
7.16 g/dL
Standard Deviation 0.31
|
—
|
—
|
—
|
—
|
|
Protein Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
7.02 g/dL
Standard Deviation 0.38
|
7.14 g/dL
Standard Deviation 0.11
|
—
|
—
|
—
|
—
|
|
Protein Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
6.96 g/dL
Standard Deviation 0.48
|
7.28 g/dL
Standard Deviation 0.33
|
—
|
—
|
—
|
—
|
|
Protein Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n =5, 5)
|
7.04 g/dL
Standard Deviation 0.29
|
7.32 g/dL
Standard Deviation 0.41
|
—
|
—
|
—
|
—
|
|
Protein Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
7.11 g/dL
Standard Deviation 0.33
|
7.26 g/dL
Standard Deviation 0.30
|
—
|
—
|
—
|
—
|
|
Protein Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
7.00 g/dL
Standard Deviation 0.35
|
7.24 g/dL
Standard Deviation 0.30
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
4.39 g/dL
Standard Deviation 0.22
|
4.63 g/dL
Standard Deviation 0.32
|
—
|
—
|
—
|
—
|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
4.32 g/dL
Standard Deviation 0.16
|
4.60 g/dL
Standard Deviation 0.37
|
—
|
—
|
—
|
—
|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
4.34 g/dL
Standard Deviation 0.17
|
4.56 g/dL
Standard Deviation 0.23
|
—
|
—
|
—
|
—
|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
4.28 g/dL
Standard Deviation 0.19
|
4.48 g/dL
Standard Deviation 0.25
|
—
|
—
|
—
|
—
|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
4.20 g/dL
Standard Deviation 0.27
|
4.60 g/dL
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
|
Albumin Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
4.32 g/dL
Standard Deviation 0.25
|
4.56 g/dL
Standard Deviation 0.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
1.73 mIU/L
Standard Deviation 0.77
|
2.35 mIU/L
Standard Deviation 1.72
|
—
|
—
|
—
|
—
|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
1.53 mIU/L
Standard Deviation 1.03
|
3.35 mIU/L
Standard Deviation 3.82
|
—
|
—
|
—
|
—
|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
1.65 mIU/L
Standard Deviation 1.08
|
3.11 mIU/L
Standard Deviation 3.65
|
—
|
—
|
—
|
—
|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
2.30 mIU/L
Standard Deviation 1.90
|
2.24 mIU/L
Standard Deviation 2.02
|
—
|
—
|
—
|
—
|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
1.73 mIU/L
Standard Deviation 0.90
|
2.30 mIU/L
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
|
Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
1.55 mIU/L
Standard Deviation 0.63
|
2.33 mIU/L
Standard Deviation 2.35
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
T4 Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
1.10 ng/dL
Standard Deviation 0.11
|
1.15 ng/dL
Standard Deviation 0.15
|
—
|
—
|
—
|
—
|
|
T4 Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
1.16 ng/dL
Standard Deviation 0.11
|
1.16 ng/dL
Standard Deviation 0.13
|
—
|
—
|
—
|
—
|
|
T4 Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
1.12 ng/dL
Standard Deviation 0.11
|
1.16 ng/dL
Standard Deviation 0.13
|
—
|
—
|
—
|
—
|
|
T4 Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
1.08 ng/dL
Standard Deviation 0.18
|
1.12 ng/dL
Standard Deviation 0.08
|
—
|
—
|
—
|
—
|
|
T4 Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
1.22 ng/dL
Standard Deviation 0.13
|
1.15 ng/dL
Standard Deviation 0.10
|
—
|
—
|
—
|
—
|
|
T4 Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
1.06 ng/dL
Standard Deviation 0.11
|
1.14 ng/dL
Standard Deviation 0.05
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
88.4 µg/dL
Standard Deviation 12.6
|
122 µg/dL
Standard Deviation 26.4
|
—
|
—
|
—
|
—
|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
77.4 µg/dL
Standard Deviation 21.5
|
119 µg/dL
Standard Deviation 39.5
|
—
|
—
|
—
|
—
|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
84.6 µg/dL
Standard Deviation 19.4
|
105 µg/dL
Standard Deviation 47.1
|
—
|
—
|
—
|
—
|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
79.2 µg/dL
Standard Deviation 21
|
82.6 µg/dL
Standard Deviation 32.6
|
—
|
—
|
—
|
—
|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
77.6 µg/dL
Standard Deviation 51.4
|
115 µg/dL
Standard Deviation 37.1
|
—
|
—
|
—
|
—
|
|
Total Iron Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
64 µg/dL
Standard Deviation 11.6
|
111 µg/dL
Standard Deviation 42.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
51.3 ng/mL
Standard Deviation 40.4
|
136 ng/mL
Standard Deviation 77.3
|
—
|
—
|
—
|
—
|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
32.0 ng/mL
Standard Deviation 24.2
|
95.2 ng/mL
Standard Deviation 57.5
|
—
|
—
|
—
|
—
|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
27.4 ng/mL
Standard Deviation 23.2
|
86.6 ng/mL
Standard Deviation 59.6
|
—
|
—
|
—
|
—
|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
21.6 ng/mL
Standard Deviation 14.7
|
85.2 ng/mL
Standard Deviation 53.1
|
—
|
—
|
—
|
—
|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
34.6 ng/mL
Standard Deviation 43.4
|
74.6 ng/mL
Standard Deviation 50.3
|
—
|
—
|
—
|
—
|
|
Ferritin Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
24.8 ng/mL
Standard Deviation 18.7
|
90.4 ng/mL
Standard Deviation 66.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
0.61 ng/mL
Standard Deviation 0.37
|
1.58 ng/mL
Standard Deviation 0.68
|
—
|
—
|
—
|
—
|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
0.80 ng/mL
Standard Deviation 0.45
|
0.97 ng/mL
Standard Deviation 0.95
|
—
|
—
|
—
|
—
|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
0.59 ng/mL
Standard Deviation 0.35
|
0.92 ng/mL
Standard Deviation 0.85
|
—
|
—
|
—
|
—
|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
1.03 ng/mL
Standard Deviation 0.56
|
1.23 ng/mL
Standard Deviation 0.82
|
—
|
—
|
—
|
—
|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
0.81 ng/mL
Standard Deviation 0.36
|
1.25 ng/mL
Standard Deviation 1.08
|
—
|
—
|
—
|
—
|
|
Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
1.09 ng/mL
Standard Deviation 0.48
|
1.42 ng/mL
Standard Deviation 1.53
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
0.79 mg/dL
Standard Deviation 0.09
|
1.05 mg/dL
Standard Deviation 0.09
|
—
|
—
|
—
|
—
|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
0.78 mg/dL
Standard Deviation 0.07
|
1.01 mg/dL
Standard Deviation 0.16
|
—
|
—
|
—
|
—
|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
0.77 mg/dL
Standard Deviation 0.08
|
1.04 mg/dL
Standard Deviation 0.11
|
—
|
—
|
—
|
—
|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
0.80 mg/dL
Standard Deviation 0.06
|
0.99 mg/dL
Standard Deviation 0.10
|
—
|
—
|
—
|
—
|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
0.84 mg/dL
Standard Deviation 0.09
|
1.02 mg/dL
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
|
Creatinine Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
0.82 mg/dL
Standard Deviation 0.13
|
1.05 mg/dL
Standard Deviation 0.10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
14.8 U/L
Standard Deviation 4.19
|
30.6 U/L
Standard Deviation 19.3
|
—
|
—
|
—
|
—
|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
13.6 U/L
Standard Deviation 4.39
|
26.2 U/L
Standard Deviation 13.5
|
—
|
—
|
—
|
—
|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
14.8 U/L
Standard Deviation 6.61
|
32.0 U/L
Standard Deviation 19.3
|
—
|
—
|
—
|
—
|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
11.2 U/L
Standard Deviation 3.11
|
29.4 U/L
Standard Deviation 17.1
|
—
|
—
|
—
|
—
|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
12.6 U/L
Standard Deviation 3.85
|
29.8 U/L
Standard Deviation 15.6
|
—
|
—
|
—
|
—
|
|
Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
15.8 U/L
Standard Deviation 4.87
|
29.8 U/L
Standard Deviation 14.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
18.8 U/L
Standard Deviation 4.63
|
22.9 U/L
Standard Deviation 4.26
|
—
|
—
|
—
|
—
|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
17.6 U/L
Standard Deviation 3.51
|
21.0 U/L
Standard Deviation 4.06
|
—
|
—
|
—
|
—
|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
20.2 U/L
Standard Deviation 8.87
|
22.4 U/L
Standard Deviation 7.02
|
—
|
—
|
—
|
—
|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
15.8 U/L
Standard Deviation 4.66
|
23.4 U/L
Standard Deviation 6.5
|
—
|
—
|
—
|
—
|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
16.8 U/L
Standard Deviation 5.36
|
23.6 U/L
Standard Deviation 4.72
|
—
|
—
|
—
|
—
|
|
Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
20.6 U/L
Standard Deviation 6.66
|
25.8 U/L
Standard Deviation 9.60
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before and at the end of cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
HDL Cholesterol Levels After 3 Months of Cobalt Supplementation
Baseline
|
85.2 mg/dL
Standard Deviation 19.0
|
50.2 mg/dL
Standard Deviation 14.1
|
—
|
—
|
—
|
—
|
|
HDL Cholesterol Levels After 3 Months of Cobalt Supplementation
Days 88 and 90
|
78.4 mg/dL
Standard Deviation 23.1
|
50.6 mg/dL
Standard Deviation 11.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before and at the end of cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Total Cholesterol Levels After 3 Months of Cobalt Supplementation
Baseline
|
209 mg/dL
Standard Deviation 31.7
|
179 mg/dL
Standard Deviation 26.6
|
—
|
—
|
—
|
—
|
|
Total Cholesterol Levels After 3 Months of Cobalt Supplementation
Days 88 and 90
|
220 mg/dL
Standard Deviation 54.6
|
188 mg/dL
Standard Deviation 46.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before and at the end of cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Triglyceride Levels After 3 Months of Cobalt Supplementation
Baseline
|
105 mg/dL
Standard Deviation 41.3
|
113 mg/dL
Standard Deviation 51.1
|
—
|
—
|
—
|
—
|
|
Triglyceride Levels After 3 Months of Cobalt Supplementation
Days 88 and 90
|
95.6 mg/dL
Standard Deviation 29.6
|
122 mg/dL
Standard Deviation 71.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)Population: Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.
Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
Baseline (n = 5, 5)
|
88.2 mg/dL
Standard Deviation 7.53
|
89.9 mg/dL
Standard Deviation 13
|
—
|
—
|
—
|
—
|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
Days 29 and 30 (n = 5, 5)
|
82.2 mg/dL
Standard Deviation 10.1
|
83.4 mg/dL
Standard Deviation 9.76
|
—
|
—
|
—
|
—
|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
Days 57 and 58 (n = 5, 5)
|
86.4 mg/dL
Standard Deviation 9.4
|
81.2 mg/dL
Standard Deviation 26.1
|
—
|
—
|
—
|
—
|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
Days 88 and 90 (n = 5, 5)
|
83.2 mg/dL
Standard Deviation 9.91
|
87.4 mg/dL
Standard Deviation 13.8
|
—
|
—
|
—
|
—
|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
1 wk postdose (n = 5, 5)
|
79.6 mg/dL
Standard Deviation 14.5
|
90.6 mg/dL
Standard Deviation 2.97
|
—
|
—
|
—
|
—
|
|
Glucose Levels After 1, 2 and 3 Months of Dosing
2 wk postdose (n = 5, 5)
|
88.4 mg/dL
Standard Deviation 15.1
|
79.4 mg/dL
Standard Deviation 9.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation
A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.
Outcome measures
| Measure |
Albumin-Co Fraction
n=5 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=5 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Cobalt Urine Concentrations
Day 14/16
|
186 µg/L
Standard Deviation 170
|
119 µg/L
Standard Deviation 114
|
—
|
—
|
—
|
—
|
|
Cobalt Urine Concentrations
Day 43/44
|
226 µg/L
Standard Deviation 228
|
46 µg/L
Standard Deviation 35
|
—
|
—
|
—
|
—
|
|
Cobalt Urine Concentrations
Day 88/90
|
193 µg/L
Standard Deviation 179
|
70 µg/L
Standard Deviation 29
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After cobalt supplementationPopulation: Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. "n" represents the number of urine samples analyzd at each time point.
A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.
Outcome measures
| Measure |
Albumin-Co Fraction
n=2 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=1 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
1 wk postdose (n = 5, 3)
|
38 µg/L
Standard Deviation 29
|
14 µg/L
Standard Deviation 6
|
—
|
—
|
—
|
—
|
|
Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
2 wk postdose (n = 4, 3)
|
19 µg/L
Standard Deviation 18
|
7 µg/L
Standard Deviation 2
|
—
|
—
|
—
|
—
|
|
Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
6 wk postdose (n = 2, 1)
|
6 µg/L
Standard Deviation 5
|
2 µg/L
Standard Deviation 0
|
—
|
—
|
—
|
—
|
|
Cobalt Urine Concentrations After Cessation of Cobalt Supplementation
10 wk postdose (n = 2, 1)
|
6 µg/L
Standard Deviation 7
|
1 µg/L
Standard Deviation 0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Cardiac Function (LVEF)
|
65.9 LVEF (2D est) (%)
Standard Deviation 4.43
|
66.8 LVEF (2D est) (%)
Standard Deviation 4.21
|
65.0 LVEF (2D est) (%)
Standard Deviation 2.54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Cardiac Function (LA Volume Index)
|
23.3 LA volume index (mL/m^2)
Standard Deviation 4.27
|
24.2 LA volume index (mL/m^2)
Standard Deviation 5.33
|
24.0 LA volume index (mL/m^2)
Standard Deviation 6.08
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function (Average RNFL Thickness)
|
97.10 Average RNFL thickness (µm)
Standard Deviation 7.89
|
97.00 Average RNFL thickness (µm)
Standard Deviation 8.67
|
97.00 Average RNFL thickness (µm)
Standard Deviation 7.89
|
96.30 Average RNFL thickness (µm)
Standard Deviation 8.64
|
96.50 Average RNFL thickness (µm)
Standard Deviation 7.81
|
96.50 Average RNFL thickness (µm)
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function (Average C:D Ratio)
Average C:D ratio
|
0.43 ratio
Standard Deviation 0.12
|
0.44 ratio
Standard Deviation 0.11
|
0.41 ratio
Standard Deviation 0.13
|
0.42 ratio
Standard Deviation 0.12
|
0.40 ratio
Standard Deviation 0.12
|
0.40 ratio
Standard Deviation 0.11
|
|
Changes in Visual Function (Average C:D Ratio)
Vertical C:D ratio
|
0.41 ratio
Standard Deviation 0.13
|
0.40 ratio
Standard Deviation 0.10
|
0.40 ratio
Standard Deviation 0.12
|
0.39 ratio
Standard Deviation 0.11
|
0.38 ratio
Standard Deviation 0.13
|
0.36 ratio
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionOphthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function (Cup Volume)
|
0.09 mm^3
Standard Deviation 0.06
|
0.08 mm^3
Standard Deviation 0.04
|
0.08 mm^3
Standard Deviation 0.05
|
0.07 mm^3
Standard Deviation 0.04
|
0.08 mm^3
Standard Deviation 0.05
|
0.07 mm^3
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionOphthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function (VFI)
|
99.40 VFI (%)
Standard Deviation 0.70
|
99.30 VFI (%)
Standard Deviation 0.82
|
99.30 VFI (%)
Standard Deviation 0.48
|
99.50 VFI (%)
Standard Deviation 0.97
|
99.60 VFI (%)
Standard Deviation 0.52
|
99.70 VFI (%)
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionOphthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Visual Function (Mean Deviation and PSD)
Mean deviation (dB)
|
-0.22 dB
Standard Deviation 1.01
|
-0.25 dB
Standard Deviation 0.78
|
0.29 dB
Standard Deviation 0.85
|
0.02 dB
Standard Deviation 0.69
|
0.26 dB
Standard Deviation 0.82
|
-0.09 dB
Standard Deviation 0.89
|
|
Changes in Visual Function (Mean Deviation and PSD)
PSD (dB)
|
1.44 dB
Standard Deviation 0.31
|
1.38 dB
Standard Deviation 0.30
|
1.37 dB
Standard Deviation 0.30
|
1.28 dB
Standard Deviation 0.13
|
1.26 dB
Standard Deviation 0.16
|
1.26 dB
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90, and \~4-6 post-weeks).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Neurological Function (Sural Sensory Amplitude)
|
24.2 Sural Sensory Amplitude (µV)
Standard Deviation 14.8
|
23.4 Sural Sensory Amplitude (µV)
Standard Deviation 14.9
|
20.7 Sural Sensory Amplitude (µV)
Standard Deviation 12.4
|
28.3 Sural Sensory Amplitude (µV)
Standard Deviation 24.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, at the study midpoint, and at the study completionPopulation: Participants that completed three months of cobalt supplementation
Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, \~day 45, \~day 90, and \~4-6 post-weeks).
Outcome measures
| Measure |
Albumin-Co Fraction
n=10 Participants
Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
|
SI After Cobalt Supplementation
n=10 Participants
Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT).
|
Study Midpoint - Left
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Midpoint - Right
n=10 Participants
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Left
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
Study Completion - Right
Comparison of hearing function in volunteers before, during, and after cobalt supplementation
|
|---|---|---|---|---|---|---|
|
Changes in Neurological Function (Velocity)
Sural Sensory Velocity
|
42.4 m/s
Standard Deviation 5.8
|
39.9 m/s
Standard Deviation 7.4
|
36.4 m/s
Standard Deviation 7.0
|
43.3 m/s
Standard Deviation 7.8
|
—
|
—
|
|
Changes in Neurological Function (Velocity)
Peroneal Motor Velocity
|
58.7 m/s
Standard Deviation 13.7
|
64.1 m/s
Standard Deviation 18.7
|
63.2 m/s
Standard Deviation 24.8
|
0 m/s
Standard Deviation 0
|
—
|
—
|
Adverse Events
Study Volunteers
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Study Volunteers
n=13 participants at risk
Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (\~2 mL) daily "in water or juice as maintenance." Dietary supplementation lasted for approximately three months.
|
|---|---|
|
General disorders
Ear pain and tinnitus associated with sinusitis
|
7.7%
1/13 • During the study: 7-8 months (approximate length of the study)
Summary of self-reported adverse events
|
|
General disorders
Migraine headaches with prior history of headache
|
7.7%
1/13 • During the study: 7-8 months (approximate length of the study)
Summary of self-reported adverse events
|
|
General disorders
Vesicular rash following vaccination
|
7.7%
1/13 • During the study: 7-8 months (approximate length of the study)
Summary of self-reported adverse events
|
|
General disorders
Rash on face, neck, upper trunk, and back with peeling skin on palms of hands on both sides
|
7.7%
1/13 • During the study: 7-8 months (approximate length of the study)
Summary of self-reported adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place