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NOT YET RECRUITING
NCT06617130
NA

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

Sponsor: Kamuzu University of Health Sciences

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Months - 36 Months

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-11-01

Completion Date

2026-12-01

Last Updated

2024-09-27

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Kamuzu University of Health Sciences

Blantyre, Malawi