A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
NCT ID: NCT01593969
Last Updated: 2014-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2012-05-31
2014-06-30
Brief Summary
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Detailed Description
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Description of Study Design: Randomized Controlled Trial
Study Duration: 6 months (Trial); 12 months (All trial-related activities)
Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.
Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.
Location: Kilifi District, coastal Kenya.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard RUTF
Standard RUTF given according to National Guidelines
Standard RUTF
Standard formulation RUTF given according to National Guidelines
RUTF/Flax Oil
RUTF/Flax Oil is reformulated RUTF to increase n3 content
RUTF/Flax Oil
Ready to Use Therapeutic Food
RUTF/Flax Oil plus additional Fish Oil
RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3
RUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food
Interventions
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RUTF/Flax Oil
Ready to Use Therapeutic Food
RUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food
Standard RUTF
Standard formulation RUTF given according to National Guidelines
Eligibility Criteria
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Inclusion Criteria
* Provision of informed consent
* Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema)
* Stabilised and eligible to receive RUTF according to national guidelines
Exclusion Criteria
* Known allergy or hypersensitivity to any of the product ingredients
* Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.
6 Months
5 Years
ALL
No
Sponsors
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KEMRI-Wellcome Trust Collaborative Research Program
OTHER
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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James A Berkley, FRCPCH
Role: PRINCIPAL_INVESTIGATOR
KEMRI-Wellcome Trust Collaborative Research Program
Locations
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Kilifi District Hospital
Kilifi, Coast, Kenya
Countries
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References
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Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.
Other Identifiers
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OPP1046183
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SSC 2157
Identifier Type: -
Identifier Source: org_study_id
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