Trial Outcomes & Findings for Personalized Vitamin D Supplementation in European and African Americans (NCT NCT02362269)
NCT ID: NCT02362269
Last Updated: 2020-12-01
Results Overview
To validate the proposed vitamin D3 dosing algorithm, a vitamin D panel consisting of serum concentrations of vitamin D3 (cholecalciferol; an indicator of vitamin D3 absorption), 25(OH)D3, 25(OH)D2, the C3-epimer of 25(OH)D3 and 24,25(OH)2D as well as an assay to directly measure free serum 25(OH)D will be run on all the blood samples collected at the baseline, 3 month and 6 month visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
3 and 6 months
Results posted on
2020-12-01
Participant Flow
Participant milestones
| Measure |
Control Group
The control group will receive 2500 IU of vitamin D3 daily.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Dosing Algorithm Group
The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
86
|
|
Overall Study
COMPLETED
|
82
|
80
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Control Group
The control group will receive 2500 IU of vitamin D3 daily.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Dosing Algorithm Group
The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
|---|---|---|
|
Overall Study
Moved
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
Baseline Characteristics
Personalized Vitamin D Supplementation in European and African Americans
Baseline characteristics by cohort
| Measure |
Control Group
n=83 Participants
The control group will receive 2500 IU of vitamin D3 daily.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Dosing Algorithm Group
n=86 Participants
The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline 25(OH)Vitamin D
|
26.4 ng/mL
STANDARD_DEVIATION 7.5 • n=5 Participants
|
27.8 ng/mL
STANDARD_DEVIATION 7.6 • n=7 Participants
|
27.0 ng/mL
STANDARD_DEVIATION 7.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 monthsTo validate the proposed vitamin D3 dosing algorithm, a vitamin D panel consisting of serum concentrations of vitamin D3 (cholecalciferol; an indicator of vitamin D3 absorption), 25(OH)D3, 25(OH)D2, the C3-epimer of 25(OH)D3 and 24,25(OH)2D as well as an assay to directly measure free serum 25(OH)D will be run on all the blood samples collected at the baseline, 3 month and 6 month visits.
Outcome measures
| Measure |
Control Group
n=82 Participants
The control group will receive 2500 IU of vitamin D3 daily.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Dosing Algorithm Group
n=80 Participants
The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
|---|---|---|
|
Efficacy of the Dosing Algorithm in Achieving Total 25(OH)D as Measured by the Percentage of Participants Ending With Concentrations of 35-50 ng/mL
3 Months
|
61.3 percentage of participants in goal range
|
58.5 percentage of participants in goal range
|
|
Efficacy of the Dosing Algorithm in Achieving Total 25(OH)D as Measured by the Percentage of Participants Ending With Concentrations of 35-50 ng/mL
6 Months
|
47.6 percentage of participants in goal range
|
50.3 percentage of participants in goal range
|
Adverse Events
Control Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Dosing Algorithm Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=82 participants at risk
The control group will receive 2500 IU of vitamin D3 daily.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
Dosing Algorithm Group
n=80 participants at risk
The dosing algorithm group will initially receive 1000, 2500, or 4000 IU of vitamin D3 daily based on the baseline 25(OH)D. This group's dosing may be adjusted at the 3-month visit.
Vitamin D: Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
|
|---|---|---|
|
Cardiac disorders
Hemorrhagic stroke
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from screening through 6 Month study visit.
|
0.00%
0/80 • Adverse events were collected from screening through 6 Month study visit.
|
|
Musculoskeletal and connective tissue disorders
Hip replacement
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from screening through 6 Month study visit.
|
0.00%
0/80 • Adverse events were collected from screening through 6 Month study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/82 • Adverse events were collected from screening through 6 Month study visit.
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from screening through 6 Month study visit.
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
0.00%
0/82 • Adverse events were collected from screening through 6 Month study visit.
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from screening through 6 Month study visit.
|
|
Renal and urinary disorders
Urothelial carcinoma
|
0.00%
0/82 • Adverse events were collected from screening through 6 Month study visit.
|
1.2%
1/80 • Number of events 1 • Adverse events were collected from screening through 6 Month study visit.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place