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Randomized Controlled Trial
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.
- Kelsey D J Jones, Rehema Ali, Maureen A Khasira, Dennis Odera, Annette L West, Grielof Koster, Peter Akomo, Alison W A Talbert, Victoria M Goss, Moses Ngari, Johnstone Thitiri, Said Ndoro, Miguel A Garcia Knight, Kenneth Omollo, Anne Ndungu, Musa M Mulongo, Paluku Bahwere, Greg Fegan, John O Warner, Anthony D Postle, Steve Collins, Philip C Calder, and James A Berkley.
- KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. kelsey.jones@imperial.ac.uk.
- Bmc Med. 2015 Apr 23; 13: 9393.
BackgroundReady-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition. Current specifications for RUTF permit a high n-6 polyunsaturated fatty acid (PUFA) content and low n-3 PUFA, with no stipulated requirements for preformed long-chain n-3 PUFA. The objective of this study was to develop an RUTF with elevated short-chain n-3 PUFA and measure its impact, with and without fish oil supplementation, on children's PUFA status during treatment of severe acute malnutrition.MethodsThis randomized controlled trial in children with severe acute malnutrition in rural Kenya included 60 children aged 6 to 50 months who were randomized to receive i) RUTF with standard composition; ii) RUTF with elevated short chain n-3 PUFA; or iii) RUTF with elevated short chain n-3 PUFA plus fish oil capsules. Participants were followed-up for 3 months. The primary outcome was erythrocyte PUFA composition.ResultsErythrocyte docosahexaenoic acid (DHA) content declined from baseline in the two arms not receiving fish oil. Erythrocyte long-chain n-3 PUFA content following treatment was significantly higher for participants in the arm receiving fish oil than for those in the arms receiving RUTF with elevated short chain n-3 PUFA or standard RUTF alone: 3 months after enrollment, DHA content was 6.3% (interquartile range 6.0-7.3), 4.5% (3.9-4.9), and 3.9% (2.4-5.7) of total erythrocyte fatty acids (P <0.001), respectively, while eicosapentaenoic acid (EPA) content was 2.0% (1.5-2.6), 0.7% (0.6-0.8), and 0.4% (0.3-0.5) (P <0.001). RUTF with elevated short chain n-3 PUFA and fish oil capsules were acceptable to participants and carers, and there were no significant differences in safety outcomes.ConclusionsPUFA requirements of children with SAM are not met by current formulations of RUTF, or by an RUTF with elevated short-chain n-3 PUFA without additional preformed long-chain n-3 PUFA. Clinical and growth implications of revised formulations need to be addressed in large clinical trials.Trial RegistrationClinicaltrials.gov NCT01593969. Registered 4 May 2012.
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