NCT02095613已完成不适用
A Randomized Trial of Ready-to-use-supplementary Food Compared to Corn-soy-blend+ as Food Rations for HIV-infected Adults on Antiretroviral Therapy in Rural Haiti
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index over time
研究概览
简要总结
The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented to have HIV infection by standard laboratory procedures
- •live in the geographic catchment area of PIH services where study is taking place
- •18 years of age or older
- •started antiretroviral therapy for HIV in the 24 months prior to study enrollment
排除标准
- •if another household member is also eligible for food assistance
- •if subject is pregnant at the time of enrollment
- •if unable to give informed consent
研究组 & 干预措施
Corn-soy-blend plus
Active Comparator
food A type of ground meal called corn-soy-blend plus
干预措施: traditional food (Other)
Ready-to-use-supplementary food
Active Comparator
food A nutrient dense food comprised of peanuts, oil, multivitamins.
干预措施: food that is nutrient dense (Other)
结局指标
主要结局
Change in Body Mass Index over time
时间窗: 6-month, 12-month
次要结局
- Change in Quality of Life over time(6-month, 12-month)
研究者
Louise Ivers, MD
Associate Physician
Brigham and Women's Hospital
研究点 (1)
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