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
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedOctober 16, 2013
October 1, 2013
2 months
January 8, 2009
October 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight gain
14 days
Secondary Outcomes (1)
weight gain
28 days
Study Arms (2)
RUTF
EXPERIMENTALRUTF supplement (Plumpynut®) of 500 kcal/day for 2 weeks
control
NO INTERVENTIONno supplement given
Interventions
Intervention group receives 500 kcal/day of RUTF for 2 weeks Control group receives no food supplement
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Hospital
Dubie, Katanga, Republic of the Congo
Related Publications (1)
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.
PMID: 22558108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saskia van der Kam, Ir
nutrition expert MSF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ir
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
January 1, 2009
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
October 16, 2013
Record last verified: 2013-10