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Sentinel Surveillance of Malnutrition, Niger

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PlumpyNut
PlumpyDoz
Sponsored by
Epicentre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring malnutrition, ready to use food, Niger

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All children resident in randomized villages 6-59 months

Exclusion Criteria:

  • N/A

Sites / Locations

    Outcomes

    Primary Outcome Measures

    weight-for-height in children 6 to 60 mo of age

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2008
    Last Updated
    May 21, 2008
    Sponsor
    Epicentre
    Collaborators
    Ministry of Health, Niger, Medecins Sans Frontieres, Netherlands
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00682708
    Brief Title
    Sentinel Surveillance of Malnutrition, Niger
    Official Title
    Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Epicentre
    Collaborators
    Ministry of Health, Niger, Medecins Sans Frontieres, Netherlands

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006. This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition
    Keywords
    malnutrition, ready to use food, Niger

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PlumpyNut
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PlumpyDoz
    Primary Outcome Measure Information:
    Title
    weight-for-height in children 6 to 60 mo of age
    Time Frame
    8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All children resident in randomized villages 6-59 months Exclusion Criteria: N/A
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rebecca F Grais
    Organizational Affiliation
    Epicentre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19155454
    Citation
    Isanaka S, Nombela N, Djibo A, Poupard M, Van Beckhoven D, Gaboulaud V, Guerin PJ, Grais RF. Effect of preventive supplementation with ready-to-use therapeutic food on the nutritional status, mortality, and morbidity of children aged 6 to 60 months in Niger: a cluster randomized trial. JAMA. 2009 Jan 21;301(3):277-85. doi: 10.1001/jama.2008.1018.
    Results Reference
    derived

    Learn more about this trial

    Sentinel Surveillance of Malnutrition, Niger

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