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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 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 169 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02362269
The ClinicalTrials.gov registry entry for NCT02362269 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin D is the first listed.
NCT02362269 reports 0 study locations.
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.
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