Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection in Karamoja, Uganda

Not Applicable

Completed

• Conditions: Infant Morbidity; Child Malnutrition

• Registration Number: NCT01497236
• Lead Sponsor: Medecins Sans Frontieres, Spain

Brief Summary

The purpose of this study is to determine whether 14 days nutritional supplementation with Ready to use therapeutic Food (RUTF) or micronutrients alone to children having an infection will prevent malnutrition and reduce the frequency of morbidity.

Detailed Description

similar to MSF-nutcon 03 : NCT01154803

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2202

Inclusion Criteria

• 6 to 59 months of age
• Not malnourished
• Diagnosis of malaria and/or diarrhoea and/or LRTI
• Intending to remain in area for the duration of the 6 month follow-up
• Living within approximately 60 minutes walking distance from the clinic
• Informed consent from a guardian*

Exclusion Criteria

• Child is exclusively breastfeeding
• Child is severely malnourished
• Presence of 'General Danger Signs'
• Presence of severe disease (including severe malaria, severe LRTI, severe diarrhoea)
• Needing hospitalisation for any reason
• Known history of allergy to the nutritional supplementation
• Having a sibling enrolled in the study*

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
"negative nutritional outcome" of a child	6 months follow-up	The incidence of a negative nutritional outcome will be defined in two different ways according to the baseline nutritional status.; i) for children with no malnourishment at time of entry into study, "negative nutritional outcome" is defined as progression to moderate or severe malnourishment ii) for children with moderate malnourishment at time of entry into study, "negative nutritional outcome" is defined as loss of ³10% of baseline weight or progression to severe malnourishment, whichever is reached first

Secondary Outcome Measures

Name	Time	Method
Number of new events of a study disease	6 months	study disease: malaria, diarrhoea, and LRTI

Trial Locations

Locations (1)

Kaabong Hospital; 🇺🇬 Kaabong, Karamoja district, Uganda