Vitamin D and Sexual Health

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Dietary Supplement: Vitamin D3 (cholecalciferol); Dietary Supplement: Placebo

• Registration Number: NCT01450462
• Lead Sponsor: Ohio State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-07
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

• speak English;
• be between 18 and 50 years old, inclusive;
• be pre-menopausal;
• have at least one ovary;
• be positive for bacterial vaginosis

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Exclusion Criteria

• pregnant at enrollment or in the previous 3 months;
• planning to become pregnant in the next six months;
• currently breastfeeding;
• currently be menstruating heavily;
• have a contraindication to oral metronidazole treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D (cholecalciferol)	Vitamin D3 (cholecalciferol)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Serum vitamin D level	24 weeks	To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks
Serum and cervical immunoinflammatory mediators	24 weeks	To assess the effect of vitamin D supplementation on levels of and correlations between BV-associated and vitamin D-associated immunoinflammatory mediators after 24 weeks
Bacterial vaginosis recurrence	24 weeks	To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis

Trial Locations

Locations (1)

Columbus Public Health Sexual Health Clinic; 🇺🇸 Columbus, Ohio, United States