Vitamin D and Sexual Health



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:September 2011
End Date:December 2012
Contact:Abigail Norris Turner, PhD
Email:ant@osumc.edu
Phone:614 366 3510

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
?
mi
from
Columbus, OH
Click here to add this to my saved trials