Clinical trial NCT06617130: The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
Official title: The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Amino Acid, Stunting, Environmental Enteric Dysfunction
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2024-09-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We hypothesize that adding 12 mg/day of indispensable amino acids (IAA) to corn-soy blend blended flour porridge will reduce gut permeability amongst 6-36 month old rural Malawian children at risk of stunting compared to providing only corn-soy blended flour porridge without addition of indispensable amino acids for a period of 4 weeks.

This will be a randomized, controlled open label parallel group efficacy clinical trial. Eligible children will be identified through a Demographic Surveillance System implemented by the study group at Mangochi district hospital. 66 children meeting set criteria will be randomised to receive corn-soy blended flour porridge (control group) or corn-soy blended flour porridge to which is added indispensable amino acids. The standard complementary food will provide 30% daily energy requirement while the amino acids in the intervention group will provide 1.5 times the estimated average requirement (EAR) for a healthy child.
Primary purpose: PREVENTION

Brief 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.


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\&lt;-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

Primary outcomes:
measure: corn soy bean flour porridge with added indespensable amino acids
timeFrame: 30 days
Secondary outcomes:
measure: Corn soy bean flour porridge
timeFrame: 30 days
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Kamuzu University of Health Sciences
Study officials:
References: