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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819858
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Saskia van der Kam, 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.

Condition or disease Intervention/treatment Phase
Weight Loss Weight Gain Convalescence Malaria Dietary Supplement: RUTF (Plumpynut®) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RUTF
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
Other Names:
  • RUTF
  • Ready to use Therapeutic Food
  • RUF
  • Lipid based food supplement

No Intervention: control
no supplement given

Primary Outcome Measures :
  1. weight gain [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. weight gain [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819858

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Central Hospital
Dubie, Katanga, Congo
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
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Principal Investigator: Saskia van der Kam, Ir nutrition expert MSF

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Saskia van der Kam, Ir, Medecins Sans Frontieres, Netherlands Identifier: NCT00819858     History of Changes
Other Study ID Numbers: MSF-nutcon01
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Saskia van der Kam, Medecins Sans Frontieres, Netherlands:
weight loss
weight gain

Additional relevant MeSH terms:
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Body Weight
Weight Loss
Weight Gain
Signs and Symptoms
Protozoan Infections
Parasitic Diseases
Body Weight Changes
Disease Attributes
Pathologic Processes