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Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality (NRCI-ASPE)

Primary Purpose

Malnutrition

Status
Completed
Phase
Phase 4
Locations
Chad
Study Type
Interventional
Intervention
Ready-to-Used Supplement Food administration
Sponsored by
France Broillet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children

Eligibility Criteria

6 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Médecins Sans Frontières-OCG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

12 months RUSF

4 months RUSF

Arm Description

Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.

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)

Outcomes

Primary Outcome Measures

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 )
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 )

Secondary Outcome Measures

Morbidity
Gain of mid-upper-arm circumference (MUAC) gain
Weight for Height gain

Full Information

First Posted
February 26, 2014
Last Updated
March 11, 2014
Sponsor
France Broillet
Collaborators
Swiss Tropical & Public Health Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02085044
Brief Title
Non Randomized Controlled Intervention Study Comparing Two Interventions of Nutritional Supplement on Malnutrition, Health and Mortality
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
France Broillet
Collaborators
Swiss Tropical & Public Health Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
malnutrition, children's health, prevention, ready-to-use supplementary food, lipid based nutrient supplement, chad, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 months RUSF
Arm Type
Experimental
Arm Description
Children between 6 to 24 months received ready-to-used supplementary food every months during the whole year.
Arm Title
4 months RUSF
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready-to-Used Supplement Food administration
Other Intervention Name(s)
Plumpy 'doz
Primary Outcome Measure Information:
Title
Incidence of acute severe malnutrition
Description
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 )
Time Frame
overall study time, 22 months
Title
Mortality rate
Description
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 )
Time Frame
overall study time 22 months
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
overall study time 22 months
Title
Gain of mid-upper-arm circumference (MUAC) gain
Time Frame
22 months
Title
Weight for Height gain
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annick Antierens
Organizational Affiliation
Medecins Sans Frontieres, Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
France Broillet
Organizational Affiliation
Medecins Sans Frontieres, Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecins Sans Frontières-OCG
City
Massakory
Country
Chad

12. IPD Sharing Statement

Learn more about this trial

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

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