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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corn soy bean flour porridge with added indespensable amino acids | Active Comparator | 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. |
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| Corn soy bean flour porridge | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| corn soy bean flour porridge with added indespensable amino acids | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Corn soy bean flour porridge | 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:
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Inclusion Criteria:
In order to be eligible to participate in the study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamuzu University of Health Sciences | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42031499 | Derived | Lee GO, Owino V, Baquiran AFP, Pasanna RM, Achoribo SE, Meskini T, Amadi B, Maleta KM, Gaudichon C, Serafico ME, Hegde S, Cabanilla CVD, Devi S, El Mzibri M, Brouwer AF, Kurpad AV, Kelly P, Morrison D. Impact of indispensable amino acid supplementation on gut function in children at high risk of environmental enteropathy: protocol for an international coordinated group of randomised controlled trials. BMJ Open. 2026 Apr 24;16(4):e105456. doi: 10.1136/bmjopen-2025-105456. |
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The Principal Investigator will determine authorship on primary and secondary publications of data derived from this trial and published by the PI's research group. De-identified data will be shared with PI approval beginning 6 months after primary trial publication with researchers that provide reasonable statistical analysis plans.
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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.
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| 30 days |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000601 | Amino Acids, Essential |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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