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

Malnutrition Clinical Trial

— NRCI-ASPE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02085044
• Other study ID #: Médecins Sans Frontières-OCG
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2014
• Last updated: March 11, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: Médecins Sans Frontières, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chad: Nutrition & Agriculture Technologies National CommitteeChad : Ministry of Public Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Ready-to-Used Supplement Food administration

Locations

Country	Name	City	State
Chad	Médecins Sans Frontières-OCG	Massakory

Sponsors (2)

Lead Sponsor	Collaborator
France Broillet	Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Chad, 

Outcome

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