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

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ClinicalTrials.gov Identifier: NCT00819858
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Saskia van der Kam, Medecins Sans Frontieres, Netherlands

January 8, 2009
January 9, 2009
October 16, 2013
January 2009
March 2009   (Final data collection date for primary outcome measure)
weight gain [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT00819858 on ClinicalTrials.gov Archive Site
weight gain [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
The Effectiveness of Ready to Use Therapeutic Food (RUTF) in Catch up Growth in Children After an Episode of P. Falciparum Malaria
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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Weight Loss
  • Weight Gain
  • Convalescence
  • Malaria
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
  • Experimental: RUTF
    RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks
    Intervention: Dietary Supplement: RUTF (Plumpynut®)
  • No Intervention: control
    no supplement given
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
160
March 2009
March 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Months to 59 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Congo
 
 
NCT00819858
MSF-nutcon01
Yes
Not Provided
Not Provided
Saskia van der Kam, Medecins Sans Frontieres, Netherlands
Medecins Sans Frontieres, Netherlands
Not Provided
Principal Investigator: Saskia van der Kam, Ir nutrition expert MSF
Medecins Sans Frontieres, Netherlands
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP