Sentinel Surveillance of Malnutrition, Niger
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PlumpyNut
PlumpyDoz
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring malnutrition, ready to use food, Niger
Eligibility Criteria
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
NCT ID
NCT00682708
First Posted
March 26, 2008
Last Updated
May 21, 2008
Sponsor
Epicentre
Collaborators
Ministry of Health, Niger, Medecins Sans Frontieres, Netherlands
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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