Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality (NRCI-ASPE)

France Broillet

Status and phase: Completed; Phase 4

Conditions: Malnutrition

Treatments: Dietary Supplement: Ready-to-Used Supplement Food administration

Study type: Interventional

Funder types: Other

Identifiers

NCT02085044

Médecins Sans Frontières-OCG

Details and patient eligibility

About

The hypothesis for the study is that 12 months of a Ready-To-Use Supplementary Food (RUSF) distributions have a greater impact on children's health than the standard RUSF distributions during the hunger gap period (june to september). We estimated that the 12 month RUSF will decrease the incidence of severe acute malnutrition by 33% compared to an administration only during the hunger gap period (4 month a year).

Enrollment: 5,700 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children between 6 months and 24 months of age

Exclusion criteria

• children who can 't swallow
• children from parents who does not want to be in the study

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5,700 participants in 2 patient groups

12 months RUSF

Experimental group

Description:

Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.

Treatment:

Dietary Supplement: Ready-to-Used Supplement Food administration

4 months RUSF

Active Comparator group

Description:

children between 6 to 24 months of one zone received a ready-to-used supplement food during the 4 months of the hunger gap period (june to september)

Treatment:

Dietary Supplement: Ready-to-Used Supplement Food administration