Trial Outcomes & Findings for Improving the Understanding of the Response to Vitamin D Supplementation (NCT NCT01465178)
NCT ID: NCT01465178
Last Updated: 2016-11-25
Results Overview
Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
Baseline, 1 and 4 months post supplementation
Results posted on
2016-11-25
Participant Flow
Enrollment started December 2011 and ended December 2014. Subjects were enrolled from the community and research was conducted at the University of Wisconsin Osteoporosis Clinical Research Program.
No adverse events were reported between screening and randomization. All screened volunteers that were not enrolled in the study were deemed ineligible based on 25(OH)vitamin D being outside the study entry criterion.
Participant milestones
| Measure |
2000 IU Vitamin D3
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
2000 IU Vitamin D3
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Improving the Understanding of the Response to Vitamin D Supplementation
Baseline characteristics by cohort
| Measure |
2000 IU Vitamin D3
n=31 Participants
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
n=31 Participants
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 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
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 and 4 months post supplementationOur primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;
Outcome measures
| Measure |
2000 IU Vitamin D3
n=30 Participants
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
n=31 Participants
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
|---|---|---|
|
Change in Serum 25-hydroxy Vitamin D3
One Month
|
6.0 ng/ml
Standard Deviation 4.1
|
-0.8 ng/ml
Standard Deviation 4.3
|
|
Change in Serum 25-hydroxy Vitamin D3
Four Month
|
10.4 ng/ml
Standard Deviation 5.8
|
0.3 ng/ml
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 months post supplementationPopulation: Postmenopausal Caucasian women with 25(OH)D \< 10 \> 30 ng/ml
Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3.
Outcome measures
| Measure |
2000 IU Vitamin D3
n=30 Participants
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
n=31 Participants
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
|---|---|---|
|
Change in Parameters of the Vitamin D Assay Panel
Cholecalciferol Month 1
|
6.7 ng/ml
Standard Deviation 4.3
|
-0.6 ng/ml
Standard Deviation 1.3
|
|
Change in Parameters of the Vitamin D Assay Panel
Cholecalciferol Month 4
|
6.7 ng/ml
Standard Deviation 5.7
|
-0.20 ng/ml
Standard Deviation 2.12
|
|
Change in Parameters of the Vitamin D Assay Panel
24,25(OH)D3 Month 1
|
0.3 ng/ml
Standard Deviation .08
|
-0.2 ng/ml
Standard Deviation 0.5
|
|
Change in Parameters of the Vitamin D Assay Panel
24,25(OH)D3 Month 4
|
1.2 ng/ml
Standard Deviation 0.91
|
-0.1 ng/ml
Standard Deviation 0.56
|
|
Change in Parameters of the Vitamin D Assay Panel
free 25(OH)D3 Month 1
|
1.3 ng/ml
Standard Deviation 1.3
|
-0.2 ng/ml
Standard Deviation 1.0
|
|
Change in Parameters of the Vitamin D Assay Panel
free 25(OH)D3 Month 4
|
2.4 ng/ml
Standard Deviation 1.9
|
-0.1 ng/ml
Standard Deviation 1.3
|
Adverse Events
2000 IU Vitamin D3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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 |
2000 IU Vitamin D3
n=31 participants at risk
Cholecalciferol 2,000 IU capsules
cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily
|
Placebo
n=31 participants at risk
Non-matching placebo, gelatin filled capsules
Placebo: matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/31 • From screening to 4m visit, period covered ~6m
|
6.5%
2/31 • Number of events 2 • From screening to 4m visit, period covered ~6m
|
|
Psychiatric disorders
Depression
|
0.00%
0/31 • From screening to 4m visit, period covered ~6m
|
6.5%
2/31 • Number of events 2 • From screening to 4m visit, period covered ~6m
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place