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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 337
- Locations
- 1
- Primary Endpoint
- Dual Sugar Absorption Test
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 12 Months to 35 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Cowpeas
Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Intervention: 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.
Intervention: 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.
Intervention: corn-soy flour (Dietary Supplement)
Outcomes
Primary Outcomes
Dual Sugar Absorption Test
Time Frame: 12 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
Time Frame: 3 months
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
Time Frame: 6 months
lactulose-mannitol ratio in urine
Secondary Outcomes
- Mannitol Excretion(12 months)
- Lactulose Excretion(12 months)
- Lactulose Excretion(3 months)
- Lactulose Excretion(6 months)
- Mannitol Excretion(3 months)
- Mannitol Excretion(6 months)