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

Phase 4

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Ready-to-Used Supplement Food administration

• Registration Number: NCT02085044
• Lead Sponsor: France Broillet

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2013-02
• Status Verified: 2013-10
• Study Completion: 2013-12
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Study First Posted: 2014-03-12
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
12 months RUSF	Ready-to-Used Supplement Food administration	Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.
4 months RUSF	Ready-to-Used Supplement Food administration	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)

Primary Outcome Measures

Name	Time	Method
Incidence of acute severe malnutrition	overall study time, 22 months	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 )
Mortality rate	overall study time 22 months	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 )

Secondary Outcome Measures

Name	Time	Method
Morbidity	overall study time 22 months
Weight for Height gain	22 months
Gain of mid-upper-arm circumference (MUAC) gain	22 months

Trial Locations

Locations (1)

Médecins Sans Frontières-OCG; 🇹🇩 Massakory, Chad