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

Not Applicable

Completed

• Conditions: Weight Loss; Convalescence; Weight Gain; Malaria
• Interventions: Dietary Supplement: RUTF (Plumpynut®)

• Registration Number: NCT00819858
• Lead Sponsor: Medecins Sans Frontieres, Netherlands

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RUTF	RUTF (Plumpynut®)	RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks

Primary Outcome Measures

Name	Time	Method
weight gain	14 days

Secondary Outcome Measures

Name	Time	Method
weight gain	28 days

Trial Locations

Locations (1)

Central Hospital; 🇨🇬 Dubie, Katanga, Congo