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

Overview

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.

Full Title of Study: “Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 15, 2017

Interventions

  • Dietary Supplement: 2 months of treatment
    • standard 2 months of treatment

Arms, Groups and Cohorts

  • Active Comparator: BP-100
    • standard treatment
  • Experimental: Num Trey
    • locally produced RUTF

Clinical Trial Outcome Measures

Primary Measures

  • weight gain
    • Time Frame: 2 months
    • weight gain in g/kg/day

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut de Recherche pour le Developpement
  • Collaborator
    • Ministry of Agriculture, Forestry and Fisheries Cambodia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Frank Wieringa, Senior Researcher – Institut de Recherche pour le Developpement

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