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临床试验/NCT01450462
NCT01450462已完成不适用

Vitamin D and Sexual Health (the DASH Study)

Ohio State University2 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2011年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abigail Norris Turner

Assistant Professor

Ohio State University

研究点 (2)

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