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

F

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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