Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM (FLNS_SAM)

May 11, 2018 updated by: Frank Wieringa, Institut de Recherche pour le Developpement

Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia

In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Cambodia
      • Phnom Penh, Cambodia
        • Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration

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:

  • discharged from hospital after admission for SAM
  • WHZ <2.8 Z-score or MUAC<11.5 cm
  • no complications
  • passing the appetite test

Exclusion Criteria:

  • <6 mo of age
  • complications related to SAM

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BP-100
standard treatment
Dietary supplement: 2 months of treatment
standard 2 months of treatment
Experimental: Num Trey
locally produced RUTF
Dietary supplement: 2 months of treatment
standard 2 months of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight gain
Time Frame: 2 months
weight gain in g/kg/day
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition
Time Frame: 2 months
changes in body composition obtained from skinfold thickness measurements over the treatment period
2 months
Fatty Acid composition
Time Frame: 2 months
changes in serum concentrations of fatty acids over the intervention period
2 months

Collaborators and Investigators

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

Sponsor

Institut de Recherche pour le Developpement

Collaborators

UNICEF
Ministry of Agriculture, Forestry and Fisheries Cambodia

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)

April 1, 2016

Primary Completion (Actual)

January 15, 2017

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRD_UNICEF_DFPTQ_SAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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