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NCT01924910 · ClinicalTrials.gov registry record · Phase 4
A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT01924910: Completed Phase 4 study, sponsored by Emory University.
NCT01924910 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01924910, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if a single dose of vitamin D administered orally in the fall will provide adequate vitamin D in healthy individuals for the duration of the winter, during which vitamin D levels are known to decrease. The investigators are also interested in finding out if this level of vitamin D will provide adequate levels for the remainder of the year. While the benefits of once-yearly vitamin D administration are clear for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with vitamin D deficiency and high bone turn-over, studies have not been performed in which high doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in healthy individuals. These findings could provide evidence to support vitamin D administration to healthy individuals in the wintertime to improve health outcomes, and provide the basis for additional studies in both healthy and sick populations.
Primary Outcome
Measure blood levels of 25(OH)D, an indicator of vitamin D status, at 10 days, 3 months, and 1 year following vitamin D or placebo dose.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT 250,000 IU cholecalciferol as single, oral dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-07 |
| Phase | Phase 4 |
What the finished NCT01924910 record still lists
NCT01924910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01924910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01924910 about?
NCT01924910 is a clinical study titled "A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults". The purpose of this study is to determine if a single dose of vitamin D administered orally in the fall will provide adequate vitamin D in healthy individuals for the duration of the winter, during which vitamin D levels are known to decrease. The investigators are also interested in finding out if ...
What is the current status of trial NCT01924910?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2012-10. Estimated completion is 2017-07.
What interventions are being tested in trial NCT01924910?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), 250,000 IU cholecalciferol as single, oral dose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01924910?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01924910's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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