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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

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ClinicalTrials.gov Identifier: NCT03407326
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
The Children's Investment Fund Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
In this clinical equivalency 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: Alternative RUTF Dietary Supplement: Standard RUTF Not Applicable

Detailed Description:

This will be a randomised, double-blinded, controlled clinical equivalency 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 (Fisher's exact 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.

Randomization will be blocked for the entire study rather than at each study site. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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.




Primary Outcome Measures :
  1. Mid-upper-arm circumference [ Time Frame: 2 to 12 weeks ]
    MUAC ≥ 12.5

  2. Weight-for-height z score [ Time Frame: 2 to 12 weeks ]
    WHZ≥-2


Secondary Outcome Measures :
  1. Adverse symptoms [ Time Frame: 2 to 12 weeks ]
    stomach pain, vomiting, diarrhoea, rash or fever



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407326


Contacts
Contact: Mark Manary 1 314 454-2178 manarymj@wustl.edu

Locations
Sierra Leone
Project Peanut Butter Recruiting
Freetown, Sierra Leone
Contact: Amir Hassan         
Sponsors and Collaborators
Washington University School of Medicine
The Children's Investment Fund Foundation

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03407326     History of Changes
Other Study ID Numbers: 201710147
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
severe acute malnutrition, SAM

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Child Nutrition Disorders
Nutrition Disorders