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

ABSTRACT

BMC Med

BACKGROUND: Ready-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. METHODS: This 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. RESULTS: Erythrocyte 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. CONCLUSIONS: PUFA 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 REGISTRATION: Clinicaltrials.gov NCT01593969. Registered 4 May 2012. Jones, K. D., Ali, R., Khasira, M. A., Odera, D., West, A. L., Koster, G., Akomo, P., Talbert, A. W., Goss, V. M., Ngari, M., Thitiri, J., Ndoro, S., Knight, M. A., Omollo, K., Ndungu, A., Mulongo, M. M., Bahwere, P., Fegan, G., Warner, J. O., Postle, A. D., Collins, S., Calder, P. C., Berkley, J. A.

Pages:93, Volume:13, Edition:4/24/2015, Date,Apr-23

Link: https://www.ncbi.nlm.nih.gov/pubmed/25902844

Notes:Jones, Kelsey D J|Ali, Rehema|Khasira, Maureen A|Odera, Dennis|West, Annette L|Koster, Grielof|Akomo, Peter|Talbert, Alison W A|Goss, Victoria M|Ngari, Moses|Thitiri, Johnstone|Ndoro, Said|Knight, Miguel A Garcia|Omollo, Kenneth|Ndungu, Anne|Mulongo, Musa M|Bahwere, Paluku|Fegan, Greg|Warner, John O|Postle, Anthony D|Collins, Steve|Calder, Philip C|Berkley, James A|eng|092654/Wellcome Trust/United Kingdom|083579/Wellcome Trust/United Kingdom|092088/Wellcome Trust/United Kingdom|093500/Wellcome Trust/United Kingdom|Randomized Controlled Trial|Research Support, Non-U.S. Gov’t|England|2015/04/24 06:00|BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.

ISBN: 1741-7015 (Electronic)|1741-7015 (Linking) Permanent ID: PMC4407555 Accession Number: 25902844

Author Address: KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. kelsey.jones@imperial.ac.uk.|Centre for Global Health Research and Section of Paediatrics, Imperial College, Norfolk Place, London, W2 1PG, UK. kelsey.jones@imperial.ac.uk.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. rali@kemri-wellcome.org.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mkhasira@kemri-wellcome.org.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. dodera@kemri-wellcome.org.|Faculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. a.west@soton.ac.uk.|Faculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. g.koster@soton.ac.uk.|Valid Nutrition, Cuibin Farm, Derry Duff, Bantry, Co., Cork, Republic of Ireland. peterakomo@validnutrition.org.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. atalbert@kemri-wellcome.org.|Southampton National Institute of Health Research Respiratory Biomedical Research Unit, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. v.ledger@soton.ac.uk.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mngari@kemri-wellcome.org.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. jthitiri@kemri-wellcome.org.|Kilifi County Hospital, Ministry of Health, Kilifi, 230-80108, Kenya. saidndoro@yahoo.com.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. miguel.garciaknight@ndm.ox.ac.uk.|Nuffield Department of Clinical Medicine, Centre for Tropical Medicine & Global Health, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK. miguel.garciaknight@ndm.ox.ac.uk.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. oduorkenneth@gmail.com.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. shiroann2001@gmail.com.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mmulongo@kemri-wellcome.org.|Valid International, 35 Leopold Street, Oxford, OX4 1TW, UK. paluku@validinternational.org.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. gfegan@kemri-wellcome.org.|Nuffield Department of Clinical Medicine, Centre for Tropical Medicine & Global Health, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK. gfegan@kemri-wellcome.org.|Centre for Global Health Research and Section of Paediatrics, Imperial College, Norfolk Place, London, W2 1PG, UK. j.o.warner@imperial.ac.uk.|Faculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. a.d.postle@soton.ac.uk.|Valid Nutrition, Cuibin Farm, Derry Duff, Bantry, Co., Cork, Republic of Ireland. steve@validinternational.org.uk.|Valid International, 35 Leopold Street, Oxford, OX4 1TW, UK. steve@validinternational.org.uk.|Faculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. p.c.calder@soton.ac.uk.|National Institute of Health Southampton Biomedical Research Centre, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. p.c.calder@soton.ac.uk.|KEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. jberkley@kemri-wellcome.org.|Nuffield Department of Clinical Medicine, Centre for Tropical Medicine & Global Health, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK. jberkley@kemri-wellcome.org.

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