The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- corn soy bean flour porridge with added indespensable amino acids
研究概览
简要总结
A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36 months with or without stunting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/
排除标准
- •assessment, consent, and randomization.
- •In order to be eligible to participate in the study, an individual must meet all of the following criteria:
- •18-36 months old (now agreed to by all countries)
- •Stunted (LAZ<-2)
- •Of either sex
- •Able and willing to undergo HIV testing
- •Parent, carer, or guardian able and willing to give written, informed consent
- •A positive HIV test result will not be an exclusion criterion.
- •Exclusion Criteria:
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Under 18 months of age
- •Over 36 months old
- •Wasted (weight-for-length Z-score less than -2)
- •Overweight (weight-for-length Z-score greater than 2)
- •Have had diarrhea (by self-report) in the preceding month
- •Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
- •Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results
研究组 & 干预措施
corn soy bean flour porridge with added indespensable amino acids
Children in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge.
The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
干预措施: Corn soy bean blended flour porridge plus indispensable amino acid (Dietary Supplement)
Corn soy bean flour porridge
Children in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child.
The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
干预措施: Corn soy bean blended flour porridge plus indispensable amino acid (Dietary Supplement)
结局指标
主要结局
corn soy bean flour porridge with added indespensable amino acids
时间窗: 30 days
Primary Efficacy Endpoint: We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting will reduce gut permeability as measured by the Lactulose:Rhamonse ratio test when provided over 30 days compared to corn-soy blended flour porridge without added IAA.
次要结局
- Corn soy bean flour porridge(30 days)