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

March 11, 2014 updated by: France Broillet

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chad
      • Massakory, Chad
        • Médecins Sans Frontières-OCG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 months RUSF
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
Other Names:
  • Plumpy 'doz
Active Comparator: 4 months RUSF
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
Other Names:
  • Plumpy 'doz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute severe malnutrition
Time Frame: overall study time, 22 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

France Broillet

Collaborators

Swiss Tropical & Public Health Institute

Investigators

  • Study Chair: Annick Antierens, Medecins Sans Frontieres, Netherlands
  • Principal Investigator: France Broillet, Medecins Sans Frontieres, Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Médecins Sans Frontières-OCG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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