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

Sponsored by:	Medecins Sans Frontieres
Information provided by:	Medecins Sans Frontieres
ClinicalTrials.gov Identifier:	NCT00819858

Purpose

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.

Condition	Intervention
Weight Loss Weight Gain Convalescence Malaria	Dietary Supplement: RUTF (Plumpynut®)

MedlinePlus related topics: Dietary Supplements Malaria Weight Control

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria

Further study details as provided by Medecins Sans Frontieres:

Primary Outcome Measures:

weight gain [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

weight gain [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	January 2009
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RUTF: Experimental RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks	Dietary Supplement: RUTF (Plumpynut®) Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
control: No Intervention no supplement given

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).

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819858

Locations

Congo, Katanga
Central Hospital
Dubie, Katanga, Congo

Sponsors and Collaborators

Medecins Sans Frontieres

Investigators

Principal Investigator:

Saskia van der Kam, Ir

nutrition expert MSF

More Information

Responsible Party:	Médecins Sans Frontières OCA ( Ir. S. van der Kam )
Study ID Numbers:	MSF-nutcon01
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819858
Health Authority:	Ministry of Health Democratic Republic of Congo: Médecin Inspecteur du Province Katanga

Keywords provided by Medecins Sans Frontieres:

weight loss
weight gain
malnutrition
convalescence
malaria

RUTF
RUF
supplementation
nutrition

Study placed in the following topic categories:

Body Weight
Protozoan Infections
Signs and Symptoms
Malnutrition
Weight Loss
Body Weight Changes

Convalescence
Parasitic Diseases
Malaria
Weight Gain
Malaria, Falciparum

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Coccidiosis

ClinicalTrials.gov processed this record on January 16, 2009