Trial Outcomes & Findings for Treatment of Vitamin D Insufficiency (NCT NCT00933244)
NCT ID: NCT00933244
Last Updated: 2015-11-10
Results Overview
Percent of calcium absorbed in the intestinal tract within one day
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
230 participants
Primary outcome timeframe
One Year
Results posted on
2015-11-10
Participant Flow
Participant milestones
| Measure |
High Dose Vitamin D
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
Placebo
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
79
|
75
|
76
|
|
Overall Study
COMPLETED
|
74
|
74
|
73
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
3
|
Reasons for withdrawal
| Measure |
High Dose Vitamin D
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
Placebo
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
3
|
Baseline Characteristics
Treatment of Vitamin D Insufficiency
Baseline characteristics by cohort
| Measure |
High Dose Vitamin D
n=79 Participants
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=75 Participants
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
Placebo
n=76 Participants
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 5 • n=5 Participants
|
60 years
STANDARD_DEVIATION 6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 6 • n=5 Participants
|
61 years
STANDARD_DEVIATION 6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
79 participants
n=5 Participants
|
75 participants
n=7 Participants
|
76 participants
n=5 Participants
|
230 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: 4% of subjects withdrew from the study. Additionally the calcium isotope dose was not recorded in 2 subjects and a urine sample was mishandled in a third. Thus, the number of participants analyzed is less than the number randomized into the trial.
Percent of calcium absorbed in the intestinal tract within one day
Outcome measures
| Measure |
Placebo
n=70 Participants
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
High Dose Vitamin D
n=74 Participants
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=74 Participants
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
|---|---|---|---|
|
Intestinal Calcium Absorption
Baseline
|
0.183 Total Fractional Calcium Absorption
Interval 0.138 to 0.221
|
0.200 Total Fractional Calcium Absorption
Interval 0.154 to 0.243
|
0.217 Total Fractional Calcium Absorption
Interval 0.168 to 0.276
|
|
Intestinal Calcium Absorption
One Year
|
0.174 Total Fractional Calcium Absorption
Interval 0.137 to 0.218
|
0.206 Total Fractional Calcium Absorption
Interval 0.168 to 0.258
|
0.172 Total Fractional Calcium Absorption
Interval 0.144 to 0.231
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Annual changes in bone mineral density were analyzed for subjects who completed the study. 9 subjects (4%) withdrew from the study, all for personal reasons. Thus, number of participants analyzed is 4% less than number of subjects randomized.
Annualized percent change in bone mineral density at spine, hip, femoral neck, and body
Outcome measures
| Measure |
Placebo
n=73 Participants
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
High Dose Vitamin D
n=74 Participants
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=74 Participants
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
|---|---|---|---|
|
Bone Mineral Density
Annualized Percent Change in BMD at Spine
|
0.2 Percent Change in Bone Mineral Density
Interval -1.7 to 2.3
|
-0.3 Percent Change in Bone Mineral Density
Interval -1.9 to 1.4
|
0.0 Percent Change in Bone Mineral Density
Interval -2.1 to 2.1
|
|
Bone Mineral Density
Annualized Percent Change in Total Hip BMD
|
-0.9 Percent Change in Bone Mineral Density
Interval -1.9 to 0.3
|
-0.2 Percent Change in Bone Mineral Density
Interval -1.3 to 0.8
|
-0.5 Percent Change in Bone Mineral Density
Interval -1.2 to 0.2
|
|
Bone Mineral Density
Annualized Percent Change in Femoral Neck BMD
|
-0.8 Percent Change in Bone Mineral Density
Interval -2.0 to -0.1
|
-0.3 Percent Change in Bone Mineral Density
Interval -1.3 to 0.6
|
-0.9 Percent Change in Bone Mineral Density
Interval -2.3 to 0.1
|
|
Bone Mineral Density
Annualized Percent Change in Total Body BMD
|
-0.5 Percent Change in Bone Mineral Density
Interval -1.6 to 1.4
|
-0.4 Percent Change in Bone Mineral Density
Interval -1.1 to 0.3
|
-0.5 Percent Change in Bone Mineral Density
Interval -3.0 to 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 30, 60, 120, 365 daysPopulation: Bone turnover markers were analyzed in duplicate for the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am.
C-telopeptide (pg/mL) was measured at baseline, 30 days, 60 days, 120 days, 365 days in the subset of subjects who arrived at all study visit fasting since midnight and had phlebotomy prior to 10 am. Data demonstrated outliers and was summarized using the median (25th, 75th interquartile range).
Outcome measures
| Measure |
Placebo
n=46 Participants
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
High Dose Vitamin D
n=51 Participants
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=52 Participants
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
|---|---|---|---|
|
Bone Turnover
C-telopeptide (pg/mL) at 60 days
|
-1 pg/mL
Interval -5.0 to 4.0
|
0 pg/mL
Interval -3.0 to 6.0
|
-1 pg/mL
Interval -5.0 to 2.0
|
|
Bone Turnover
C-telopeptide (pg/mL) at Baseline
|
98 pg/mL
Interval 78.0 to 110.0
|
81 pg/mL
Interval 74.0 to 101.0
|
97 pg/mL
Interval 80.0 to 107.0
|
|
Bone Turnover
C-telopeptide (pg/mL) at 30 days
|
0 pg/mL
Interval -6.0 to 5.0
|
2 pg/mL
Interval -5.0 to 5.0
|
1 pg/mL
Interval -3.0 to 4.0
|
|
Bone Turnover
C-telopeptide (pg/mL) at 120 days
|
-2 pg/mL
Interval -5.0 to 3.0
|
1 pg/mL
Interval -3.0 to 8.0
|
-1 pg/mL
Interval -5.0 to 2.0
|
|
Bone Turnover
C-telopeptide (pg/mL) at 365 days
|
0 pg/mL
Interval -5.0 to 5.0
|
2 pg/mL
Interval -3.0 to 8.0
|
0 pg/mL
Interval -4.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearPopulation: 4% of subjects withdrew from the study and muscle tests were not conducted in four additional subjects who sustained injury or reported leg pain during a study visit. Thus the number analyzed is less than the number randomized into the trial.
We summarized within-arm one-year changes in continuous muscle outcomes using the mean (95% confidence interval).
Outcome measures
| Measure |
Placebo
n=73 Participants
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
High Dose Vitamin D
n=74 Participants
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=73 Participants
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
|---|---|---|---|
|
Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test
One Year Change in Timed Up and Go Test (seconds)
|
-0.35 seconds
Interval -0.7 to -0.01
|
-0.38 seconds
Interval -0.66 to -0.11
|
-0.44 seconds
Interval -0.66 to -0.22
|
|
Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test
One Year Change in Five Sit-to-Stand Test (sec)
|
-0.55 seconds
Interval -1.02 to -0.07
|
-1.04 seconds
Interval -1.44 to -0.63
|
-0.98 seconds
Interval -1.49 to -0.47
|
Adverse Events
High Dose Vitamin D
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
Low Dose Vitamin D
Serious events: 7 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Dose Vitamin D
n=79 participants at risk
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=75 participants at risk
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
Placebo
n=76 participants at risk
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.5%
2/79 • Number of events 2
|
2.7%
2/75 • Number of events 2
|
5.3%
4/76 • Number of events 4
|
|
General disorders
Hospitalization
|
1.3%
1/79 • Number of events 1
|
1.3%
1/75 • Number of events 1
|
1.3%
1/76 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/79
|
1.3%
1/75 • Number of events 1
|
0.00%
0/76
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
0.00%
0/79
|
2.7%
2/75 • Number of events 2
|
0.00%
0/76
|
|
Renal and urinary disorders
Hypercalciuria
|
5.1%
4/79 • Number of events 7
|
1.3%
1/75 • Number of events 1
|
1.3%
1/76 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
Other adverse events
| Measure |
High Dose Vitamin D
n=79 participants at risk
Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.
High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
Low Dose Vitamin D
n=75 participants at risk
Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.
Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.
Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
|
Placebo
n=76 participants at risk
Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.
Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.
Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.
Placebo: White gel-cap placebo pills to take orally, daily for 355 days.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System
|
1.3%
1/79 • Number of events 1
|
4.0%
3/75 • Number of events 3
|
1.3%
1/76 • Number of events 1
|
|
Cardiac disorders
Cardiac
|
10.1%
8/79 • Number of events 9
|
16.0%
12/75 • Number of events 12
|
7.9%
6/76 • Number of events 6
|
|
Congenital, familial and genetic disorders
Congenital
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
|
Ear and labyrinth disorders
Ear and Labyrinth
|
0.00%
0/79
|
1.3%
1/75 • Number of events 1
|
0.00%
0/76
|
|
Endocrine disorders
Endocrine
|
5.1%
4/79 • Number of events 4
|
4.0%
3/75 • Number of events 3
|
5.3%
4/76 • Number of events 5
|
|
Eye disorders
Eye
|
3.8%
3/79 • Number of events 3
|
5.3%
4/75 • Number of events 5
|
2.6%
2/76 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal
|
17.7%
14/79 • Number of events 18
|
25.3%
19/75 • Number of events 23
|
19.7%
15/76 • Number of events 22
|
|
General disorders
General
|
3.8%
3/79 • Number of events 3
|
4.0%
3/75 • Number of events 3
|
7.9%
6/76 • Number of events 6
|
|
Hepatobiliary disorders
Hepatobiliary
|
1.3%
1/79 • Number of events 1
|
1.3%
1/75 • Number of events 1
|
0.00%
0/76
|
|
Immune system disorders
Immune System
|
2.5%
2/79 • Number of events 2
|
6.7%
5/75 • Number of events 7
|
7.9%
6/76 • Number of events 8
|
|
Infections and infestations
Infection and Infestation
|
54.4%
43/79 • Number of events 70
|
56.0%
42/75 • Number of events 73
|
48.7%
37/76 • Number of events 80
|
|
Injury, poisoning and procedural complications
Injury, poisoning, procedural
|
3.8%
3/79 • Number of events 3
|
0.00%
0/75
|
1.3%
1/76 • Number of events 1
|
|
Investigations
Investigations
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition
|
5.1%
4/79 • Number of events 4
|
4.0%
3/75 • Number of events 3
|
2.6%
2/76 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, Connective Tissue
|
55.7%
44/79 • Number of events 83
|
69.3%
52/75 • Number of events 98
|
69.7%
53/76 • Number of events 102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm, Benign, Malignant
|
5.1%
4/79 • Number of events 4
|
0.00%
0/75
|
5.3%
4/76 • Number of events 4
|
|
Nervous system disorders
Nervous System
|
11.4%
9/79 • Number of events 11
|
6.7%
5/75 • Number of events 5
|
13.2%
10/76 • Number of events 11
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, Peuperium, Perinatal
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
|
Psychiatric disorders
Psychiatric
|
3.8%
3/79 • Number of events 3
|
4.0%
3/75 • Number of events 3
|
7.9%
6/76 • Number of events 6
|
|
Renal and urinary disorders
Renal and Urinary
|
6.3%
5/79 • Number of events 8
|
4.0%
3/75 • Number of events 4
|
3.9%
3/76 • Number of events 3
|
|
Reproductive system and breast disorders
Reproductive and Breast
|
5.1%
4/79 • Number of events 4
|
1.3%
1/75 • Number of events 1
|
2.6%
2/76 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, Mediastinal
|
8.9%
7/79 • Number of events 7
|
1.3%
1/75 • Number of events 1
|
10.5%
8/76 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue
|
11.4%
9/79 • Number of events 9
|
10.7%
8/75 • Number of events 8
|
11.8%
9/76 • Number of events 11
|
|
Social circumstances
Social Circumstances
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
8.9%
7/79 • Number of events 8
|
14.7%
11/75 • Number of events 12
|
14.5%
11/76 • Number of events 13
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/79
|
0.00%
0/75
|
0.00%
0/76
|
Additional Information
Dr. Karen E Hansen
University of Wisconsin - School of Medicine & Public Health
Phone: 608-265-8162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place