NCT06617130

The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Kamuzu University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Amino Acid, Stunting, Environmental Enteric Dysfunction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Corn soy bean blended flour porridge plus indispensable amino acid	Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive corn-soy bean blended flour porridge supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) dosed at 12g/d and providing 1.5 times the estimated average requirement (EAR) for a healthy child (Intervention group). The porridge will provide 30% daily energy requirement. The study foods will be taken once daily by the child with at least three observed feeding sessions per week over the 4 weeks of the study to assess compliance. Children in the control arm will receive corn-soy blended flour porridge without added amino acids.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: Malawi