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

French Public Scientific and Technological Institution (EPST)

Status: Unknown

Conditions: Treatment; Malnutrition; Children

Treatments: Dietary Supplement: 2 months of treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02907424

IRD_UNICEF_DFPTQ_SAM

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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120 participants in 2 patient groups

BP-100

Active Comparator group

Description:

standard treatment

Treatment:

Dietary Supplement: 2 months of treatment

Num Trey

Experimental group

Description:

locally produced RUTF

Treatment:

Dietary Supplement: 2 months of treatment