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

NCT06617130 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-09-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • Kamuzu University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-08-01
Completion
2026-12-01

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617130 on ClinicalTrials.gov