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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00682708
Other study ID # 07056
Secondary ID
Status Completed
Phase N/A
First received March 26, 2008
Last updated May 21, 2008
Start date August 2006
Est. completion date March 2008

Study information

Verified date May 2008
Source Epicentre
Contact n/a
Is FDA regulated No
Health authority Niger: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 59 Months
Eligibility Inclusion Criteria:

- All children resident in randomized villages 6-59 months

Exclusion Criteria:

Study Design

Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PlumpyNut

PlumpyDoz


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Epicentre Medecins Sans Frontieres, Ministry of Health, Niger

Outcome

Type Measure Description Time frame Safety issue
Primary weight-for-height in children 6 to 60 mo of age 8 months No
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