Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Dual Sugar Absorption Test
研究概览
简要总结
To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
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
- Single (Investigator)
入排标准
- 年龄范围
- 12 Months 至 35 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
- •aged 12-35 months
- •youngest eligible child in each household
排除标准
- •Unable to drink 20 mL of sugar water
- •Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- •Apparent need for acute medical treatment for an illness or injury
- •Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
研究组 & 干预措施
Cowpeas
Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
干预措施: cowpeas complementary food (Dietary Supplement)
Common bean
Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
干预措施: common bean complementary food (Dietary Supplement)
Corn Soy Flour
Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
干预措施: corn-soy flour (Dietary Supplement)
结局指标
主要结局
Dual Sugar Absorption Test
时间窗: 12 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
时间窗: 3 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
时间窗: 6 months
lactulose-mannitol ratio in urine
次要结局
- Mannitol Excretion(12 months)
- Lactulose Excretion(12 months)
- Lactulose Excretion(3 months)
- Lactulose Excretion(6 months)
- Mannitol Excretion(3 months)
- Mannitol Excretion(6 months)