Sentinel Surveillance of Malnutrition, Niger

This study has been completed.

Sponsor:

Collaborators:

Ministry of Health, Niger

Medecins Sans Frontieres, Netherlands

Information provided by:

Epicentre

ClinicalTrials.gov Identifier:

NCT00682708

First received: March 26, 2008

Last updated: May 21, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

May 21, 2008

Start Date ^ICMJE

August 2006

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

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

Completion Date

March 2008

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

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

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