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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Nutritional Supplementation (RUTF and Multi Micronutrient) in Preventing Malnutrition in Children 6-59 Months With Infection (Malaria, Pneumonia, Diarrhoea), a Randomized Controlled T

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 Summary: similar to MSF-nutcon 03 : NCT01154803
Sponsor: Medecins Sans Frontieres, Spain

Current Primary Outcome: "negative nutritional outcome" of a child [ Time Frame: 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



Original Primary Outcome: Same as current

Current Secondary Outcome: Number of new events of a study disease [ Time Frame: 6 months ]

study disease: malaria, diarrhoea, and LRTI


Original Secondary Outcome: Same as current

Information By: Medecins Sans Frontieres, Spain

Dates:
Date Received: December 20, 2011
Date Started: March 2011
Date Completion:
Last Updated: June 29, 2015
Last Verified: June 2015