Vitamin D and Sexual Health (the DASH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Serum vitamin D level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •speak English;
- •be between 18 and 50 years old, inclusive;
- •be pre-menopausal;
- •have at least one ovary;
- •be positive for bacterial vaginosis
排除标准
- •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
结局指标
主要结局
Serum vitamin D level
时间窗: 24 weeks
To assess the effect of vitamin D supplementation on serum vitamin D levels after 24 weeks
Serum and cervical immunoinflammatory mediators
时间窗: 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
时间窗: 24 weeks
To assess the effect of high-dose vitamin D on recurrence of bacterial vaginosis
次要结局
未报告次要终点
研究者
Abigail Norris Turner
Assistant Professor
Ohio State University
