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

Medecins Sans Frontieres, Spain2,202 enrolled

Overview

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.

similar to MSF-nutcon 03 : NCT01154803

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

2,202

Conditions

Child Malnutrition Infant Morbidity

Interventions

Dietary Supplement: Nutrition supplement with RUTF or MNPDIETARY_SUPPLEMENT

14 days nutritional supplementation with either * a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients * a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake * a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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\*

Locations (1)

Kaabong Hospital

Kaabong, Karamoja District, Uganda

Outcomes

Primary Outcomes

"negative nutritional outcome" of a child

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

Time frame: 6 months follow-up

Secondary Outcomes

Number of new events of a study disease

study disease: malaria, diarrhoea, and LRTI

Time frame: 6 months

Data from ClinicalTrials.gov

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