Malnutrition Clinical Trial
— NRCI-ASPEOfficial title:
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
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).
Status | Completed |
Enrollment | 5700 |
Est. completion date | December 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 24 Months |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Chad | Médecins Sans Frontières-OCG | Massakory |
Lead Sponsor | Collaborator |
---|---|
France Broillet | Swiss Tropical & Public Health Institute |
Chad,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Morbidity | overall study time 22 months | No | |
Secondary | Gain of mid-upper-arm circumference (MUAC) gain | 22 months | No | |
Secondary | Weight for Height gain | 22 months | No |
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