Sentinel Surveillance of Malnutrition, Niger

Tracking Information
First Submitted Date ICMJE	March 26, 2008
First Posted Date ICMJE	May 22, 2008
Last Update Posted Date	May 22, 2008
Study Start Date ICMJE	August 2006
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 21, 2008)	weight-for-height in children 6 to 60 mo of age [ Time Frame: 8 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Sentinel Surveillance of Malnutrition, Niger
Official Title ICMJE	Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Primary Purpose: Prevention
Condition ICMJE	Malnutrition
Intervention ICMJE	Dietary Supplement: PlumpyNut; Dietary Supplement: PlumpyDoz
Study Arms	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	March 2008
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: All children resident in randomized villages 6-59 months Exclusion Criteria:
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Months to 59 Months (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00682708
Other Study ID Numbers ICMJE	07056
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rebecca Freeman Grais, epidemiologist, Epicentre
Study Sponsor ICMJE	Epicentre
Collaborators ICMJE	Ministry of Health, Niger; Medecins Sans Frontieres, Netherlands
Investigators ICMJE	Principal Investigator: Rebecca F Grais Epicentre
PRS Account	Epicentre
Verification Date	May 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP