NCT02472301

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 337 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 12 Months – 35 Months
• Healthy volunteers: Accepted

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.

Conditions

• Environmental Enteropathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cowpeas complementary food	cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
DIETARY_SUPPLEMENT	corn-soy flour	Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
DIETARY_SUPPLEMENT	common bean complementary food	common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-06-15
• Last updated: 2017-05-11

Locations

1 site across 1 country: Malawi