The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

The Washington University

Status: Completed

Conditions: Environmental Enteropathy

Treatments: Dietary Supplement: common bean complementary food; Dietary Supplement: corn-soy flour; Dietary Supplement: cowpeas complementary food

Study type: Interventional

Funder types: Other

Identifiers

NCT02472301

LG2

Details and patient eligibility

About

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.

Enrollment: 337 patients

Sex: All

Ages: 12 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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337 participants in 3 patient groups

Cowpeas

Experimental group

Description:

Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Treatment:

Dietary Supplement: cowpeas complementary food

Common bean

Experimental group

Description:

Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Treatment:

Dietary Supplement: common bean complementary food

Corn Soy Flour

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: corn-soy flour