Back to resultsEffect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
Primary Purpose
Weight Loss, Weight Gain, Convalescence
Status
Completed
Phase
Not Applicable
Locations
Congo
Study Type
Interventional
Intervention
RUTF (Plumpynut®)
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss focused on measuring weight loss, weight gain, malnutrition, convalescence, malaria, RUTF, RUF, supplementation, nutrition
Eligibility 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.
Sites / Locations
- Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RUTF
control
Arm Description
RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks
no supplement given
Outcomes
Primary Outcome Measures
weight gain
Secondary Outcome Measures
weight gain
Full Information
NCT ID
NCT00819858
First Posted
January 8, 2009
Last Updated
October 15, 2013
Sponsor
Medecins Sans Frontieres, Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT00819858
Brief Title
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medecins Sans Frontieres, Netherlands
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Gain, Convalescence, Malaria
Keywords
weight loss, weight gain, malnutrition, convalescence, malaria, RUTF, RUF, supplementation, nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RUTF
Arm Type
Experimental
Arm Description
RUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks
Arm Title
control
Arm Type
No Intervention
Arm Description
no supplement given
Intervention Type
Dietary Supplement
Intervention Name(s)
RUTF (Plumpynut®)
Other Intervention Name(s)
RUTF, Ready to use Therapeutic Food, RUF, Lipid based food supplement
Intervention Description
Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
Primary Outcome Measure Information:
Title
weight gain
Time Frame
14 days
Secondary Outcome Measure Information:
Title
weight gain
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saskia van der Kam, Ir
Organizational Affiliation
nutrition expert MSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital
City
Dubie
State/Province
Katanga
Country
Congo
12. IPD Sharing Statement
Citations:
PubMed Identifier
22558108
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Ready to Use Therapeutic Food (RUTF) Supplement After an Episode of Malaria Falciparum on Weight
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