Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight

Study Overview
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Brief Summary
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The primary objective of this study is to determine to what extent provision with RUTF will promote catch up growth in children following an acute uncomplicated episode of P. falciparum malaria.

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. Children aged 6-59 months presenting with malaria caused by P. falciparum who are provided with a RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks will show significantly better catch up growth compared to a similar patient group not provided with RUTF (at 2 weeks and 4 weeks post-intervention).

Official Title
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The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria

Conditions
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Weight Loss, Weight Gain, Convalescence, Malaria

Intervention / Treatment
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* Dietary Supplement: RUTF (Plumpynut®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 to 59 months, and Positive rapid diagnostic test (Paracheck®) and Thick smear showing infection with P. falciparum and Informed consent from parents or guardian aged at least 18 years. Exclusion Criteria: Children who are exclusively breast fed or Children who are severely malnourished (MUAC <110 mm and/or bilateral oedema, or WHO weight-for-Height criteria <3 Z-scores) or Presence of general danger signs or signs of severe malaria as defined by the WHO criteria, or Known history of allergy to malaria drugs, or 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RUTF<br>RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks | Dietary Supplement: RUTF (Plumpynut®)<br>* Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement<br>* Other names: Lipid based food supplement;|
| No Intervention: control<br>no supplement given | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, weight gain, malnutrition, convalescence, malaria, RUTF, RUF, supplementation, nutrition