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

Primary Purpose

Malnutrition, Children, Treatment

Status
Unknown status
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
2 months of treatment
Sponsored by
Institut de Recherche pour le Developpement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BP-100

Num Trey

Arm Description

standard treatment

locally produced RUTF

Outcomes

Primary Outcome Measures

weight gain
weight gain in g/kg/day

Secondary Outcome Measures

body composition
changes in body composition obtained from skinfold thickness measurements over the treatment period
Fatty Acid composition
changes in serum concentrations of fatty acids over the intervention period

Full Information

First Posted
September 12, 2016
Last Updated
May 11, 2018
Sponsor
Institut de Recherche pour le Developpement
Collaborators
Ministry of Agriculture, Forestry and Fisheries Cambodia, UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT02907424
Brief Title
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM
Acronym
FLNS_SAM
Official Title
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherche pour le Developpement
Collaborators
Ministry of Agriculture, Forestry and Fisheries Cambodia, UNICEF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Children, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BP-100
Arm Type
Active Comparator
Arm Description
standard treatment
Arm Title
Num Trey
Arm Type
Experimental
Arm Description
locally produced RUTF
Intervention Type
Dietary Supplement
Intervention Name(s)
2 months of treatment
Intervention Description
standard 2 months of treatment
Primary Outcome Measure Information:
Title
weight gain
Description
weight gain in g/kg/day
Time Frame
2 months
Secondary Outcome Measure Information:
Title
body composition
Description
changes in body composition obtained from skinfold thickness measurements over the treatment period
Time Frame
2 months
Title
Fatty Acid composition
Description
changes in serum concentrations of fatty acids over the intervention period
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
City
Phnom Penh
Country
Cambodia

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31973779
Citation
Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Angkeabos N, Moniboth D, Berger J, Stark KD, Roos N. Whole-blood PUFA and associations with markers of nutritional and health status in acutely malnourished children in Cambodia. Public Health Nutr. 2020 Apr;23(6):974-986. doi: 10.1017/S1368980019003744. Epub 2020 Jan 24.
Results Reference
derived

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

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