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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02085044
Acronym
NRCI-ASPE
Enrollment
5700
Registered
2014-03-12
Start date
2012-02-29
Completion date
2013-12-31
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children

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).

Interventions

DIETARY_SUPPLEMENTReady-to-Used Supplement Food administration

Sponsors

Swiss Tropical & Public Health Institute
CollaboratorOTHER
France Broillet
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of acute severe malnutritionoverall study time, 22 monthsIncidence 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 rateoverall study time 22 monthsMortality 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

MeasureTime frame
Morbidityoverall study time 22 months
Gain of mid-upper-arm circumference (MUAC) gain22 months
Weight for Height gain22 months

Countries

Chad

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026