Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Medecins Sans Frontieres
ClinicalTrials.gov Identifier:
NCT00819858
First received: January 8, 2009
Last updated: November 13, 2009
Last verified: November 2009
History of Changes
  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®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 180
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Additional Information:
abstract symposium: scientific day MSF UK 2009 june 11  This link exits the ClinicalTrials.gov site

No publications provided by Medecins Sans Frontieres

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ir. S. van der Kam, Médecins Sans Frontières OCA
ClinicalTrials.gov Identifier: NCT00819858     History of Changes
Other Study ID Numbers: MSF-nutcon01
Study First Received: January 8, 2009
Last Updated: November 13, 2009
Health Authority: Barbados: Ministry of Health

Keywords provided by Medecins Sans Frontieres:
weight loss
weight gain
malnutrition
convalescence
malaria
 RUTF
RUF
supplementation
nutrition

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

ClinicalTrials.gov processed this record on June 17, 2013