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

Study Overview
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Brief Summary
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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).

Official Title
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Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality in Children Aged 6 to 24 Month Hadjer-Lamis Region - Chad

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Ready-to-Used Supplement Food administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 months RUSF<br>Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year. | Dietary Supplement: Ready-to-Used Supplement Food administration<br> <br> * Other names: Plumpy 'doz;|
| Active Comparator: 4 months RUSF<br>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) | Dietary Supplement: Ready-to-Used Supplement Food administration<br> <br> * Other names: Plumpy 'doz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ) | 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 ) | overall study time 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | overall study time 22 months | 
| Gain of mid-upper-arm circumference (MUAC) gain |  | 22 months | 
| Weight for Height gain |  | 22 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children