Effectiveness of Nutritional Supplementation in Preventing Malnutrition in Children With Infection

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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Anorexia due to infection might lead to weight loss. In many settings total recovery is problematic what might result in a permanent lower weight. A short period high quality food supplementation could improve weight gain after an infection. A complete high quality food will be tested, but also micronutrients alone as there is no information on what children with an infection exactly need as a supplement. Children aged 6-59 months presenting with diarrhoea, malaria or lower respiratory tract infection (LRTI) are provided for 2 weeks with RUTF supplement (Plumpynut®) of 500 kcal/day Multi-micronutrient powder (MNP) Placebo to MNP The followup period is 6 months. Anthropometric indicators and morbidity are assessed monthly. Participants are invited to attend the study clinic if any signs of disease are noticed.

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 Nigeria

Conditions
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Malnutrition, Malaria, Lower Respiratory Tract Infection, Diarrhoea

Intervention / Treatment
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* Dietary Supplement: Ready to Use Therapeutic Food (RUTF)
* Dietary Supplement: Micronutrient Powder (MNP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 to 59 months of age Not malnourished or moderately acutely malnourished children 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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No

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: Ready to Use Therapeutic Food (RUTF)<br>500 kcal /day for 2 weeks | Dietary Supplement: Ready to Use Therapeutic Food (RUTF)<br>* 1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)<br>* Other names: RUTF: Nutriset;|
| Experimental: Micronutrient Powder (MNP)<br>2 x 1 g sachets micronutrients /day for 2 weeks | Dietary Supplement: Micronutrient Powder (MNP)<br>* 2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)<br>* Other names: MNP: DSM;|
| No Intervention: no supplement<br>no supplementation | |

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supplementation, RUTF, Micronutrients, Plumpynut, Mixme, sprinkles, convalescence, weight, morbidity