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Completed

NCT Number: NCT01450462

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% 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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbus Public Health Sexual Health Clinic

Columbus, Ohio, 43215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Serum vitamin D level

    Time frame: 24 weeks

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

  2. Serum and cervical immunoinflammatory mediators

    Time frame: 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

  3. Bacterial vaginosis recurrence

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Vitamin D and Sexual Health (the DASH Study)

Acronym: DASH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 12, 2011
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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