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

NCT ID: NCT02085044

Last Updated: 2014-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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12 months RUSF

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

Group Type EXPERIMENTAL

Ready-to-Used Supplement Food administration

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type ACTIVE_COMPARATOR

Ready-to-Used Supplement Food administration

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ready-to-Used Supplement Food administration

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Plumpy 'doz

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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France Broillet

OTHER

Sponsor Role lead

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role collaborator

Responsible Party

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France Broillet

Chargé de recherche operationnelle

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Annick Antierens

Role: STUDY_CHAIR

Medecins Sans Frontieres, Netherlands

France Broillet

Role: PRINCIPAL_INVESTIGATOR

Medecins Sans Frontieres, Netherlands

Locations

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Médecins Sans Frontières-OCG

Massakory, , Chad

Site Status

Countries

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Chad

Other Identifiers

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Médecins Sans Frontières-OCG

Identifier Type: -

Identifier Source: org_study_id

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