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

N/ACompletedNCT00819858

Medecins Sans Frontieres, Netherlands180 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

180

Conditions

Weight Loss Weight Gain Convalescence Malaria

Interventions

RUTF (Plumpynut®)DIETARY_SUPPLEMENT

Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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.

Locations (1)

Central Hospital

Dubie, Katanga, Republic of the Congo

Outcomes

Primary Outcomes

weight gain

Time frame: 14 days

Secondary Outcomes

weight gain

Time frame: 28 days

Data from ClinicalTrials.gov

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