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

The Washington University

Status: Completed

Conditions: Severe Acute Malnutrition

Treatments: Drug: Amoxicillin; Dietary Supplement: HO-RUTF; Dietary Supplement: S-RUTF; Dietary Supplement: D-HO-RUTF

Study type: Interventional

Funder types: Other

Identifiers

NCT03094247

MMPUFA17

Details and patient eligibility

About

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.

Enrollment: 2,897 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,897 participants in 3 patient groups

Conventional RUTF (S-RUTF)

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: S-RUTF

Drug: Amoxicillin

High oleic RUTF (HO-RUTF)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: HO-RUTF

Drug: Amoxicillin

DHA-supplemented HO-RUTF (D-HO-RUTF)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: D-HO-RUTF

Drug: Amoxicillin