Vitamin D and Sexual Health (DASH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abigail Norris Turner, Ohio State University
ClinicalTrials.gov Identifier:
NCT01450462
First received: October 7, 2011
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Bacterial Vaginosis
Dietary Supplement: Vitamin D3 (cholecalciferol)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Sexual Health (the DASH Study)

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Serum vitamin D level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks

  • Serum and cervical immunoinflammatory mediators [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis


Enrollment: 118
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D (cholecalciferol) 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 Comparator: Placebo Dietary Supplement: 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450462

Locations
United States, Ohio
Columbus Public Health Sexual Health Clinic
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Abigail Norris Turner, PhD Assistant Professor
  More Information

No publications provided

Responsible Party: Abigail Norris Turner, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01450462     History of Changes
Other Study ID Numbers: KL2RR025754-ANT
Study First Received: October 7, 2011
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014