Sentinel Surveillance of Malnutrition, Niger
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ClinicalTrials.gov Identifier: NCT00682708 |
Recruitment Status
:
Completed
First Posted
: May 22, 2008
Last Update Posted
: May 22, 2008
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Tracking Information | ||||
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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 |
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Primary Purpose: Prevention | |||
Condition ICMJE | Malnutrition | |||
Intervention ICMJE |
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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. |
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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:
Exclusion Criteria: |
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Sex/Gender |
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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 |
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Investigators ICMJE |
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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 |