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NCT02362269 · ClinicalTrials.gov registry record · NA
Personalized Vitamin D Supplementation in European and African Americans
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 169
- Enrollment target
NCT02362269: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT02362269 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 169 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02362269, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 169 participants
- Enrollment target
Study Summary
The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334 community-dwelling post-menopausal women of European and African descent (\~167 from each ancestry) in a 1:1 ratio between the control arm and the dosing algorithm arm using stratified block randomization with a block size of six and stratification by site (ancestry). The sample size of 334 includes 10% over-recruitment to allow for loss to follow-up. The European ancestry women will be seen in the Madison clinic and the African ancestry women will be seen in the Milwaukee clinic. The proposed study will focus on post-menopausal women because this is the subset of the population that both Dr. Engelman's and Dr. Binkley's preliminary data are drawn from. Moreover, 25(OH)D concentrations are typically lower in women and in older individuals, since production of vitamin D in the skin following sun exposure decreases with age. Therefore, this group of individuals is likely to benefit the most from vitamin D supplementation, especially when personalized based on biology using the proposed dosing algorithm.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2015-10-30 |
| Est. Completion | 2019-05-03 |
| Phase | NA |
What the finished NCT02362269 record still lists
NCT02362269 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D is the first listed.
NCT02362269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02362269 about?
NCT02362269 is a clinical study titled "Personalized Vitamin D Supplementation in European and African Americans". The proposed study is a randomized, double-blind, controlled, multi-center clinical trial of six months of daily oral vitamin D3 (cholecalciferol). This study will randomize 334 community-dwelling post-menopausal women of European and African descent (\~167 from each ancestry) in a 1:1 ratio between...
What is the current status of trial NCT02362269?
This trial is currently completed. It is a NA study. The enrollment target is 169 participants. The study started on 2015-10-30. Estimated completion is 2019-05-03.
What interventions are being tested in trial NCT02362269?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02362269?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02362269's enrollment target sits among peer trials
169 619th of 2000 higher than 1,382 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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