Vitamin D and Sexual Health

NCT01450462 | Completed DMC

• 2 other identifiers: KL2RR025754-ANTKL2RR025754
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (3)

• Serum vitamin D level

  To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks

  24 weeks

• 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

• Bacterial vaginosis recurrence

  To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis

  24 weeks

Study Arms (2)

Vitamin D (cholecalciferol)

EXPERIMENTAL

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

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

Vitamin D (cholecalciferol)

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Columbus Public Health Sexual Health Clinic

Columbus, Ohio, 43215, United States

Location

Related Publications (1)

• Turner AN, Carr Reese P, Fields KS, Anderson J, Ervin M, Davis JA, Fichorova RN, Roberts MW, Klebanoff MA, Jackson RD. A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis. Am J Obstet Gynecol. 2014 Nov;211(5):479.e1-479.e13. doi: 10.1016/j.ajog.2014.06.023. Epub 2014 Jun 17.

  PMID: 24949544 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Abigail Norris Turner, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

US (1)