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

January 8, 2020 updated by: Washington University School of Medicine

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 of the Western Rural Region and Pujehun District of Sierra Leone

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a randomised, triple-blinded, controlled clinical non-inferiority trial assessing the treatment of SAM with one of two therapeutic foods until the child is recovered or for a period of up to 12 weeks.

Subjects will be recruited from rural health clinics in the Western Rural Region and Pujehun District of Sierra Leone, due to the limited accessibility of treatment programs in this area; investigators believe a clinical trial in this district will be beneficial.

Sierra Leonean children aged 6-59 months with uncomplicated SAM (with WHZ < -3, MUAC of <11.5 cm, or bipedal edema) will be recruited at health clinics in the Western Rural Region and Pujehun District. A total of 1,300 children will be enrolled for a total sample size of 1,262 (631 per treatment) from 30 PHU centers, to detect a 5% difference in recovery rates between any two foods, with 95% sensitivity and 80% power, assuming that the standard recovery rate is 85% and a binary non-inferiority test.

After screening and enrolment, each child's participation will last up to 12 weeks. If a child recovers before the end of the 12-week period, a child's WHZ reaches and stays above -2 for two consecutive visits without edema, the child will graduate from the study. No study food products will be given to children after 12 weeks of participation; those who have not recovered will be taken for inpatient treatment. Children will enter the study on a rolling enrolment basis and will continue to be enrolled until 1,300 children complete the study.

Random allocation of food intervention will be conducted by nurses who will have the caregiver draw opaque envelopes containing one of 4 colours. Caretakers chose a sealed envelope that contains 1 of 4 colours: 2 of these colours correspond to the control food and 2 to the experimental food. The colour will be recorded separately from the child's clinical measurements and researchers involved in the randomization process do not know which colour corresponds to which food corresponding to one of the therapeutic foods. The code will be accessible only to the food distribution personnel, who do not assess participant outcomes or eligibility. Investigators performing clinical assessments and caretakers will be blinded to the child's assigned food group.

A sub-set of participants in the main study will undergo eye-tracking testing to evaluate neurocognitive function and recovery in children with severe acute malnutrition after receiving therapeutic food.

Study Type

Interventional

Enrollment (Actual)

1568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Children aged 6-59 months with one or combination of the following

  • WHZ < -3
  • MUAC <11.5cm
  • bipedal edema

Exclusion Criteria:

  • children currently involved in another research trial or feeding program
  • developmentally delayed
  • chronic debilitating illness (such as cerebral palsy)
  • history of peanut or milk allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alternative
Participants will receive approximately 190 kcal/kg/day of alternative RUTF till recovery or up to 12 weeks of treatment.
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.
Active Comparator: Standard
Participants will receive approximately 190 kcal/kg/day of standard RUTF till recovery or up to 12 weeks of treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid-upper-arm circumference
Time Frame: 2 to 12 weeks
MUAC ≥ 12.5
2 to 12 weeks
Weight-for-height z score
Time Frame: 2 to 12 weeks
WHZ≥-2
2 to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse symptoms
Time Frame: 2 to 12 weeks
stomach pain, vomiting, diarrhoea, rash or fever
2 to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

The Children's Investment Fund Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Actual)

September 2, 2019

Study Completion (Actual)

September 2, 2019

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201710147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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