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NCT01375010 · ClinicalTrials.gov registry record · Phase 1
Vitamin D HIV Study on Postmenopausal Women
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT01375010: Completed Phase 1 study, sponsored by Columbia University.
NCT01375010 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375010, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.
Primary Outcome
Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months
Interventions
- OTHER Placebo
- DRUG Vitamin D3
- DRUG Vitamin Supplements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
What the finished NCT01375010 record still lists
NCT01375010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01375010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01375010 about?
NCT01375010 is a clinical study titled "Vitamin D HIV Study on Postmenopausal Women". The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also r...
What is the current status of trial NCT01375010?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2011-01. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01375010?
The interventions under investigation include: Placebo (OTHER), Vitamin D3 (DRUG), Vitamin Supplements (DRUG).
Who is sponsoring clinical trial NCT01375010?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01375010's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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