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

Launched by KAMUZU UNIVERSITY OF HEALTH SCIENCES · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding special amino acids to the typical foods given to children can help reduce a condition called Environmental Enteric Dysfunction (EED). EED is a gut problem that can affect children's growth and health, especially in areas where malnutrition is a concern. The trial will involve healthy children from Malawi, aged between 18 and 36 months, some of whom may be experiencing stunting, which means they are shorter than expected for their age due to poor nutrition.

To take part in this study, children must be within the specified age range and meet certain health criteria, such as not being wasted or overweight. Parents or guardians will need to provide consent for their child to participate and will also be asked if the child can have an HIV test, although a positive result won't exclude them from the study. Participants will receive either the standard complementary food or the food with added amino acids, and researchers will monitor their progress over time. This trial is important as it aims to find effective ways to improve the health and growth of vulnerable children.

Gender

ALL

Eligibility criteria

• 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:
• • 1. 18-36 months old (now agreed to by all countries)
• • 2. Stunted (LAZ\<-2)
• • 3. Of either sex
• • 4. Able and willing to undergo HIV testing
• • 5. Parent, carer, or guardian able and willing to give written, informed consent
• • 6. 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:
• • 1. Under 18 months of age
• • 2. Over 36 months old
• • 3. Wasted (weight-for-length Z-score less than -2)
• • 4. Overweight (weight-for-length Z-score greater than 2)
• • 5. Have had diarrhea (by self-report) in the preceding month
• • 6. Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
• • 7. 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