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

NCT ID: NCT00819858

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

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).

Conditions

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Weight Loss Weight Gain Convalescence Malaria

Keywords

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weight loss weight gain malnutrition convalescence malaria RUTF RUF supplementation nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RUTF

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

Group Type EXPERIMENTAL

RUTF (Plumpynut®)

Intervention Type DIETARY_SUPPLEMENT

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

control

no supplement given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RUTF (Plumpynut®)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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RUTF Ready to use Therapeutic Food RUF Lipid based food supplement

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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medecins Sans Frontieres, Netherlands

OTHER

Sponsor Role lead

Responsible Party

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Saskia van der Kam

Ir

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saskia van der Kam, Ir

Role: PRINCIPAL_INVESTIGATOR

nutrition expert MSF

Locations

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Central Hospital

Dubie, Katanga, Republic of the Congo

Site Status

Countries

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Republic of the Congo

References

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van der Kam S, Swarthout T, Niragira O, Froud A, Sompwe EM, Mills C, Roll S, Tinnemann P, Shanks L. Ready-to-use therapeutic food for catch-up growth in children after an episode of Plasmodium falciparum malaria: an open randomised controlled trial. PLoS One. 2012;7(4):e35006. doi: 10.1371/journal.pone.0035006. Epub 2012 Apr 25.

Reference Type DERIVED
PMID: 22558108 (View on PubMed)

Other Identifiers

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MSF-nutcon01

Identifier Type: -

Identifier Source: org_study_id