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

NCT03094247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2897

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Severe Acute Malnutrition

Interventions

DRUG

Amoxicillin

All patients with severe acute malnutrition will receive a course of amoxicillin.

DIETARY_SUPPLEMENT

HO-RUTF

HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts

DIETARY_SUPPLEMENT

D-HO-RUTF

D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts

DIETARY_SUPPLEMENT

S-RUTF

S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts

Sponsors & Collaborators

  • University of Texas at Austin

    collaborator OTHER

  • Cornell University

    collaborator OTHER

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2021-03-23
Completion
2021-03-23

Countries

  • Malawi

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03094247 on ClinicalTrials.gov