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NCT01932788 · ClinicalTrials.gov registry record · Phase 3
Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation
A Phase 3 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 342
- Enrollment target
NCT01932788: Completed Phase 3 study, sponsored by Medical University of South Carolina.
NCT01932788 is a Phase 3 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 342 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01932788, a Phase 3 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 342 participants
- Enrollment target
Study Summary
The purpose of this study is to give all mothers the best chance for a healthy pregnancy through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds who will receive either the current vitamin D standard of 400 IU/day (in the prenatal vitamin) or 4000 IU/day (dose found in previous pregnancy studies to achieve vitamin D sufficiency). This research is sponsored by the W.K. Kellogg Foundation and the Medical University of South Carolina. The purpose of this study is to examine the effectiveness and infection-fighting properties of the body in relationship to vitamin D levels. This study is being done at the Medical University of South Carolina (MUSC) clinics, and will involve approximately 450 volunteers.
Primary Outcome
Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who had greater than 100 nmol/L of 25(OH)D. Recording will be counts of participants in each arm that achieved greater than the 100 nmol/L threshold.
Interventions
- DRUG Vitamin D3 4000 IU in gummy form
- DRUG Placebo gummy vitamin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2013-01 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 3 |
What the finished NCT01932788 record still lists
NCT01932788 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Vitamin D3 4000 IU in gummy form is the first listed.
NCT01932788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01932788 about?
NCT01932788 is a clinical study titled "Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation". The purpose of this study is to give all mothers the best chance for a healthy pregnancy through vitamin D supplementation. We will study women of diverse racial/ethnic backgrounds who will receive either the current vitamin D standard of 400 IU/day (in the prenatal vitamin) or 4000 IU/day (dose fou...
What is the current status of trial NCT01932788?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 342 participants. The study started on 2013-01. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01932788?
The interventions under investigation include: Vitamin D3 4000 IU in gummy form (DRUG), Placebo gummy vitamin (DRUG).
Who is sponsoring clinical trial NCT01932788?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01932788's enrollment target sits among peer trials
342 1053rd of 2000 higher than 948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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