Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Infant Weight
研究概览
简要总结
This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their infants.
详细描述
In resource poor regions of the world where HIV is endemic, especially countries in sub-Saharan Africa, nutrition plays a critical role in HIV disease. Nutrition affects the health of HIV-infected women and children, and may influence the risk of mother to infant transmission of HIV through breast milk. Nutrition influences the risk of tuberculosis (TB) and TB disease severity. Existing research has focused on the role of micronutrients in HIV disease outcomes but has not addressed the role of protein calorie supplementation (PCS) in subpopulations of patients with HIV disease at high risk, specifically, HIV-infected women who are either breast feeding or have active TB. Our hypotheses are that administration of a culturally acceptable PCS is a practical, sustainable and effective strategy to: 1) decrease HIV viral load in plasma and breast milk of breast feeding women, enhance passively transferred immune mediators in breast milk, and improve HIV outcomes in women and their breast-fed infants and, 2) decrease HIV viral load, enhance TB-specific T cell immunity, and improve outcomes in women with HIV and active TB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV+ women
- •2nd trimester of pregnancy
- •Residency in Dar for duration of breastfeeding
- •Plan to exclusively breastfeed
排除标准
- •High risk pregnancy (e.g., diabetes, pre-eclampsia)
- •Women with allergy to components of PCS
研究组 & 干预措施
protein calorie supplement
250 gm daily of specially designed porridge plus standard multivitamin
干预措施: Porridge protein calorie supplement (Dietary Supplement)
Multivitamin
Standard multivitamin control
干预措施: multivitamin (Dietary Supplement)
结局指标
主要结局
Infant Weight
时间窗: 3 months
Infant weight at 3 months
次要结局
- Maternal BMI at 9 Months(9 months)
研究者
C. Fordham von Reyn
Professor of Medicine
Dartmouth-Hitchcock Medical Center
