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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02907424
Acronym
FLNS_SAM
Enrollment
120
Registered
2016-09-20
Start date
2016-04-01
Completion date
2019-05-31
Last updated
2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Malnutrition, Treatment

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.

Interventions

DIETARY_SUPPLEMENT2 months of treatment

standard 2 months of treatment

Sponsors

Ministry of Agriculture, Forestry and Fisheries Cambodia
CollaboratorUNKNOWN
UNICEF
CollaboratorOTHER
Institut de Recherche pour le Developpement
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
weight gain2 monthsweight gain in g/kg/day

Secondary

MeasureTime frameDescription
body composition2 monthschanges in body composition obtained from skinfold thickness measurements over the treatment period
Fatty Acid composition2 monthschanges in serum concentrations of fatty acids over the intervention period

Countries

Cambodia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026