ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D and Sexual Health (DASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01450462
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Abigail Norris Turner, Ohio State University

October 7, 2011
October 12, 2011
December 4, 2013
September 2011
January 2013   (Final data collection date for primary outcome measure)
  • Serum vitamin D level [ Time Frame: 24 weeks ]
    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 ]
    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 ]
    To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis
Same as current
Complete list of historical versions of study NCT01450462 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vitamin D and Sexual Health
Vitamin D and Sexual Health (the DASH Study)
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Vaginosis
  • 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
  • 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
  • Experimental: Vitamin D (cholecalciferol)
    Intervention: Dietary Supplement: Vitamin D3 (cholecalciferol)
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
150
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01450462
KL2RR025754-ANT
KL2RR025754 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Abigail Norris Turner, Ohio State University
Ohio State University
Not Provided
Principal Investigator: Abigail Norris Turner, PhD Assistant Professor
Ohio State University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP