Vitamin D and Sexual Health

Bacterial Vaginosis Clinical Trial

— DASH  

Official title:

Vitamin D and Sexual Health (the DASH Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450462
• Other study ID #: KL2RR025754-ANT
• Status: Completed
• Phase: N/A
• First received: October 7, 2011
• Last updated: December 3, 2013
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• Vitamin D3 (cholecalciferol)
Women in the vitamin D arm take 50,000 international units (IU) of vitamin D3 (cholecalciferol) weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
• Placebo
Women in the placebo arm will take their matching supplement weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments

Locations

Country	Name	City	State
United States	Columbus Public Health Sexual Health Clinic	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum vitamin D level	To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks	24 weeks	No
Primary	Serum and cervical immunoinflammatory mediators	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	24 weeks	No
Primary	Bacterial vaginosis recurrence	To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis	24 weeks	No