MedTrace Logo

Comparison of an Alternative Therapeutic Food for the International Food Aid Market to a Standard Ready-to-use Therapeutic Food (RUTF) for the Treatment of Severe Acute Malnutrition in Children

NCT03407326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1568

Last updated 2020-01-13

No results posted yet for this study

Summary

In this clinical non-inferiority trial, two foods will be compared for the treatment of SAM, testing the hypothesis that the difference in recovery rates and growth between the two test groups will be no greater than 5 percent.

Conditions

  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Alternative RUTF

The alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier.

DIETARY_SUPPLEMENT

Standard RUTF

Standard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier.

Sponsors & Collaborators

  • The Children's Investment Fund Foundation

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-09-02
Completion
2019-09-02

Countries

  • Sierra Leone

Study Locations

More Related Trials

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 NCT03407326 on ClinicalTrials.gov