Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality

Phase 4CompletedNCT02085044

France Broillet5,700 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

5,700

Conditions

Malnutrition

Interventions

Ready-to-Used Supplement Food administrationDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 24 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Médecins Sans Frontières-OCG

Massakory, Chad

Outcomes

Primary Outcomes

Incidence of acute severe malnutrition

Incidence of acute severe malnutrition will be assessed for the overall 2 years. Estimation if incidence will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )

Time frame: overall study time, 22 months

Mortality rate

Mortality will be assessed for the overall 2 years. Estimation will include children from their entry in the study to their exit of study (disharge as 24 months, dead of Lost of follow up )

Time frame: overall study time 22 months

Secondary Outcomes

Morbidity

Time frame: overall study time 22 months

Gain of mid-upper-arm circumference (MUAC) gain

Time frame: 22 months

Weight for Height gain

Time frame: 22 months

Data from ClinicalTrials.gov

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