Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development

Study Overview
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Brief Summary
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An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.

Official Title
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Improved Polyunsaturated Ready-to-use Therapeutic Food for Improved Neurocognitive Outcomes in Severe Acute Malnutrition

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Drug: Amoxicillin
* Dietary Supplement: HO-RUTF
* Dietary Supplement: D-HO-RUTF
* Dietary Supplement: S-RUTF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-59 months An acceptable appetite defined by the ability to consume 30 grams RUTF within 20 minutes Mid Upper Arm Circumference <11.5 cm, weight-for-height z-score < -3, or bilateral pitting edema on the dorsum of the feet Exclusion Criteria: Participation in any other ongoing study or supplementary feeding program Children with a chronic medical condition, including cerebral palsy, static encephalopathy, congenital heart disease, gastrointestinal disease, or peanut allergy

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional RUTF (S-RUTF)<br>This is the control group for the study, which will receive the international standard of care therapeutic food. S-RUTF is made with conventional peanuts, which are inherently high in omega-6 linoleic acid. | Drug: Amoxicillin<br>* All patients with severe acute malnutrition will receive a course of amoxicillin.<br>* Other names: Amoxil;Dietary Supplement: S-RUTF<br>* S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts<br>|
| Experimental: High oleic RUTF (HO-RUTF)<br>The treatment provided to children randomized to this arm of the study includes nutritional content comparable to S-RUTF with the exception of a low lineoleic acid/high oleic acid ratio formulated with high oleic content peanuts. | Drug: Amoxicillin<br>* All patients with severe acute malnutrition will receive a course of amoxicillin.<br>* Other names: Amoxil;Dietary Supplement: HO-RUTF<br>* HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts<br>|
| Experimental: DHA-supplemented HO-RUTF (D-HO-RUTF)<br>The treatment provided to children randomized to this arm of the study mirrors that provided by HO-RUTF with that addition of supplemental DHA at a level higher than attainable with optimal precursors. | Drug: Amoxicillin<br>* All patients with severe acute malnutrition will receive a course of amoxicillin.<br>* Other names: Amoxil;Dietary Supplement: D-HO-RUTF<br>* D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive outcome | Measured by score on the Malawian Developmental Assessment Test (MDAT). The scale is continuous and interval in nature, the range varies by population The scale title is Malawi Developmental Assessment Tool z-score The primary outcome is Global z-score, titled Global z-sore Secondary outcomes are 4 sub-domain z-scores are titled Gross motor z-score, Fine motor z-score, Language z-score, and Social z-score | Time Frame: 4 to 7 months after nutritional outcome | 
| Neurocognitive outcome | Defined by Willatts intention score adapted for field training, 3 problems to be tested. The scale is ordinal in nature, with higher values indicated better scores The scale title is Intention Score Problem 1 is scored 0 - 4 Problem 2 is scored 0 - 4 Problem 3 is scored 0 - 8 | Time Frame: within 4 weeks after nutritional outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional recovery | Defined by resolution of edema AND mid-upper arm circumference [MUAC] >12.4cm, AND/OR a weight/height z-score [WHZ] >-3 | Up to 12 weeks following enrollment | 
| Attentional orienting speed | Measured by mean saccade latency to peripheral targets | 4-7 months after nutritional after nutritional outcome | 
| Adverse Events | Measured by number of days diarrhea and/or rashes. | Fortnightly follow up visits up to 12 weeks following enrollment | 
| Acceptance of RUTF | Mother's report of if the child ate the food well. This is a yes or no question. | Fortnightly follow up visits up to 12 weeks following enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Micronutrients, Polyunsaturated fatty acids, Ready-to-use therapeutic foods, Omega-3 fatty acids, Peanuts