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

Not Applicable

Completed

• Conditions: Severe Acute Malnutrition
• Interventions: Drug: Amoxicillin; Dietary Supplement: S-RUTF; Dietary Supplement: HO-RUTF; Dietary Supplement: D-HO-RUTF

• Registration Number: NCT03094247
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Study Start: 2017-10-02
• Primary Completion: 2021-03-23
• Study Completion: 2021-03-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2897

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional RUTF (S-RUTF)	S-RUTF	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.
High oleic RUTF (HO-RUTF)	HO-RUTF	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.
DHA-supplemented HO-RUTF (D-HO-RUTF)	D-HO-RUTF	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.
Conventional RUTF (S-RUTF)	Amoxicillin	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.
High oleic RUTF (HO-RUTF)	Amoxicillin	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.
DHA-supplemented HO-RUTF (D-HO-RUTF)	Amoxicillin	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.

Primary Outcome Measures

Name	Time	Method
Neurocognitive outcome	Time Frame: within 4 weeks after nutritional 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Malawi College of Medicine; 🇲🇼 Blantyre, Malawi