Pilot Study of PUFA-optimized RUTF for Severe Acute Malnutrition
A Randomized, Double-blind Pilot Study of Polyunsaturated Fatty Acid-optimized Ready-to-use Therapeutic Food, Compared to Standard RUTF, in the Therapy of Severe Acute Malnutrition
1 other identifier
interventional
141
1 country
1
Brief Summary
To test whether a ready-to-use therapeutic food (RUTF) enriched with polyunsaturated fatty acids (RUTF-P) is as effective for the treatment of severe acute malnutrition (SAM) as standard RUTF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
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
First Submitted
Initial submission to the registry
January 31, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 29, 2014
September 1, 2014
5 months
January 31, 2014
September 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
DHA Level
Blood plasma docosahexaenoic acid (DHA) levels
4 weeks
EPA Level
Blood plasma eicosapentaenoic acid (EPA) levels
4 weeks
Secondary Outcomes (4)
Recovery Rate
12 weeks
Linear Growth
12 weeks
Ponderal Growth
12 weeks
Growth
12 weeks
Study Arms (2)
RUTF
ACTIVE COMPARATORStandard RUTF at a dose of 175 kcal/kg/d
RUTF-P
EXPERIMENTALRUTF fortified with polyunsaturated fatty acids (PUFA) at a dose of 175 kcal/kg/d
Interventions
Eligibility Criteria
You may qualify if:
- kwashiorkor and/or marasmus
- months of age
- lives in local area near enrollment site
You may not qualify if:
- recent (\<4 months) therapeutic feeding for moderate or severe acute malnutrition
- chronic medical condition (eg, Down syndrome, other congenital syndrome, chronic heart disease) that may make feeding and growth difficult (not to include HIV or TB)
- caretaker refusal of 2 blood draws
- ineligibility for outpatient therapy (ie, severe illness or anorexia requiring inpatient therapy)
- caretaker expresses plans to move away from local area of clinic, making followup difficult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- University of Malawicollaborator
Study Sites (1)
University of Malawi College of Medicine
Blantyre, Malawi
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Manary, MD
Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Kenneth Maleta, MBBS PhD
University of Malawi
- PRINCIPAL INVESTIGATOR
Chrissie Thakwalakwa
University of Malawi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2014
First Posted
February 4, 2014
Study Start
February 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 29, 2014
Record last verified: 2014-09