Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM
FLNS_SAM
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 16, 2018
May 1, 2018
10 months
September 12, 2016
May 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
weight gain
weight gain in g/kg/day
2 months
Secondary Outcomes (2)
body composition
2 months
Fatty Acid composition
2 months
Study Arms (2)
BP-100
ACTIVE COMPARATORstandard treatment
Num Trey
EXPERIMENTALlocally produced RUTF
Interventions
Eligibility Criteria
You may qualify if:
- discharged from hospital after admission for SAM
- WHZ \<2.8 Z-score or MUAC\<11.5 cm
- no complications
- passing the appetite test
You may not qualify if:
- \<6 mo of age
- complications related to SAM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut de Recherche pour le Developpementlead
- Ministry of Agriculture, Forestry and Fisheries Cambodiacollaborator
- UNICEFcollaborator
Study Sites (1)
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
Phnom Penh, Cambodia
Related Publications (2)
Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Stark KD, Roos N. Changes in polyunsaturated fatty acids during treatment of malnourished children may be insufficient to reach required essential fatty acid levels - A randomised controlled trial. Clin Nutr. 2023 Sep;42(9):1778-1787. doi: 10.1016/j.clnu.2023.08.003. Epub 2023 Aug 6.
PMID: 37572581DERIVEDSigh 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.
PMID: 31973779DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
September 12, 2016
First Posted
September 20, 2016
Study Start
April 1, 2016
Primary Completion
January 15, 2017
Study Completion
May 1, 2019
Last Updated
May 16, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share