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NCT01450462 · ClinicalTrials.gov registry record · NA
Vitamin D and Sexual Health
A NA study of Bacterial Vaginosis, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT01450462 is a NA study of Bacterial Vaginosis that has completed, run by Ohio State University. The registered enrollment target is 118 participants, below the 330-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01450462, a NA study of Bacterial Vaginosis, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Vitamin D3 (cholecalciferol)
Study Locations (1)
Ohio
- Columbus Public Health Sexual Health Clinic - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01450462
The ClinicalTrials.gov registry entry for NCT01450462 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 330-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (64% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bacterial Vaginosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01450462 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT01450462 about?
NCT01450462 is a clinical study titled "Vitamin D and Sexual Health". Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increas...
What is the current status of trial NCT01450462?
This trial is currently completed. It is a NA study. The enrollment target is 118 participants. The study started on 2011-09. Estimated completion is 2013-01.
What conditions does trial NCT01450462 study?
This clinical trial studies the following conditions: Bacterial Vaginosis.
What interventions are being tested in trial NCT01450462?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Vitamin D3 (cholecalciferol) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01450462?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01450462 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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