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NCT Number: NCT06617130

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

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.

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Key information

Conditions

Amino Acid, Stunting, Environmental Enteric Dysfunction Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.

In order to be eligible to participate in the study, an individual must meet all of the following criteria:

  • 18-36 months old (now agreed to by all countries)
  • Stunted (LAZ<-2)
  • Of either sex
  • Able and willing to undergo HIV testing
  • Parent, carer, or guardian able and willing to give written, informed consent
  • A positive HIV test result will not be an exclusion criterion.

Exclusion criteria

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Under 18 months of age
  • Over 36 months old
  • Wasted (weight-for-length Z-score less than -2)
  • Overweight (weight-for-length Z-score greater than 2)
  • Have had diarrhea (by self-report) in the preceding month
  • Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
  • Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results

Treatment and study plan

Corn soy bean blended flour porridge plus indispensable amino acid

Dietary Supplement

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.

Primary outcomes

  1. corn soy bean flour porridge with added indespensable amino acids

    Time frame: 30 days

    Primary Efficacy Endpoint:

    We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting will reduce gut permeability as measured by the Lactulose:Rhamonse ratio test when provided over 30 days compared to corn-soy blended flour porridge without added IAA.

Secondary outcomes

  1. Corn soy bean flour porridge

    Time frame: 30 days

    We hypothesize that adding 12mg IAA to corn-soy blended flour porridge provided to Malawian children aged 18-36 months with or without stunting when provided over 30 days compared to corn-soy blended flour porridge without added IAA will:

    • Increase gut digestive capacity
    • Increase plasma protein absorption
    • Reduce gut bacterial translocation
    • Reduce gut bacterial damage
    • Increase child weight
    • Increase plasma circulating amino acids
    • Increase gut microbial abundance and diversity
    • Increase fat free mass index and fat free percentage

Sponsors and collaborators

Lead sponsor

Kamuzu University of Health Sciences

Other

Collaborators

  • University of Glasgow

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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