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

Study Overview
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Brief Summary
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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
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similar to MSF-nutcon 03 : NCT01154803

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

Conditions
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Child Malnutrition, Infant Morbidity

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP


Participation Criteria
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Eligibility Criteria
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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*

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Ready to Use Terapeutic Food (RUTF)<br> | Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP<br>* 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<br>* Other names: Placebo: DSM;|
| Experimental: Multi Micronutrient Powder (MNP)<br> | Dietary Supplement: Dietary Supplement: Nutrition supplement with RUTF or MNP<br>* 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<br>* Other names: Placebo: DSM;|
| No Intervention: no supplement<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new events of a study disease | study disease: malaria, diarrhoea, and LRTI | 6 months |