The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition
NCT ID: NCT06617130
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
66 participants
INTERVENTIONAL
2024-11-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
SINGLE
Study Groups
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corn soy bean flour porridge with added indespensable amino acids
Children in the intervention arm will receive corn-soy blended flour porridge mixed with IAA. The CSB flour will be packed in 1kg packets while the IAA will be packed in small plastic bags. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child. Pre-weighed IAA will be provided so that mothers can mix the IAA to the prepared CSB porridge.
The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
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.
Corn soy bean flour porridge
Children in the control arm children will receive corn-soy blended flour porridge only. The CSB flour will be packed in 1kg packets. Parent/caretakers will be taught how to prepare complementary porridge and will be provided utensils to estimate amounts of porridge to give to the child.
The amount of porridge to be given to the child is estimated at 75g cooked porridge or 5 tablespoons of porridge. Likuni porridge is estimated to provide 403kcal per 100g when prepared using a standard recipe (Malawi Food and Nutrient Database). Based on the age range of the participating children we aim to provide an average of 250-302 kcal per child per day.
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.
Interventions
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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.
Eligibility Criteria
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Exclusion 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.
* 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
18 Months
36 Months
ALL
Yes
Sponsors
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University of Glasgow
OTHER
Kamuzu University of Health Sciences
OTHER
Responsible Party
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Locations
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Kamuzu University of Health Sciences
Blantyre, , Malawi
Countries
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Facility Contacts
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Kenneth Maleta, PhD
Role: primary
Andrew Matchado, PhD
Role: backup
Kenneth Maleta, PhD
Role: backup
Other Identifiers
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P.02/23/3992
Identifier Type: -
Identifier Source: org_study_id