Malnutrition Clinical Trial
— FLNS_SAMOfficial title:
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
Verified date | May 2018 |
Source | Institut de Recherche pour le Developpement |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | May 2019 |
Est. primary completion date | January 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 5 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Cambodia | Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration | Phnom Penh |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherche pour le Developpement | Ministry of Agriculture, Forestry and Fisheries Cambodia, UNICEF |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight gain | weight gain in g/kg/day | 2 months | |
Secondary | body composition | changes in body composition obtained from skinfold thickness measurements over the treatment period | 2 months | |
Secondary | Fatty Acid composition | changes in serum concentrations of fatty acids over the intervention period | 2 months |
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