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Clinical trialNCT01450462CompletedInterventional

Vitamin D and Sexual Health

SponsorOhio State UniversityEnrollment118Bacterial Vaginosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Columbus Public Health Sexual Health Clinic

    Columbus, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2011
Primary completion
31 Jan 2013
Completion
31 Jan 2013
Last update posted
4 Dec 2013
Registered enrollment
118
Registry id
NCT01450462

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.