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临床试验/NCT01461863
NCT01461863已完成不适用

Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2011年10月最近更新:
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
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

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

Active Comparator

250 gm daily of specially designed porridge plus standard multivitamin

干预措施: Porridge protein calorie supplement (Dietary Supplement)

Multivitamin

Placebo Comparator

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

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

C. Fordham von Reyn

Professor of Medicine

Dartmouth-Hitchcock Medical Center

研究点 (1)

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