Evidence map›Paper›PMID 25902844›Full record

Trial reportBMC medicine2015

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 and 13 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01593969 (A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition), which is not on this map. Cited by 34 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 7 pooled it
3.9field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01593969 phase2completednot on this map

A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition

TypeinterventionalSponsorUniversity of OxfordRan2012 to 2014Enrolled60ConditionsSevere Acute MalnutritionArmsRUTF/Flax Oil, RUTF/Flax Oil plus additional Fish Oil, Standard RUTF
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 7 syntheses or guidelines pooled it, 57 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 7 institutions in 4 countries.

Kelsey D J JonesKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. kelsey.jones@imperial.ac.uk.
Rehema AliKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. rali@kemri-wellcome.org.
Maureen A KhasiraKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mkhasira@kemri-wellcome.org.
Dennis OderaKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. dodera@kemri-wellcome.org.
Annette L WestFaculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. a.west@soton.ac.uk.
Grielof KosterFaculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. g.koster@soton.ac.uk.
Peter AkomoValid Nutrition, Cuibín Farm, Derry Duff, Bantry, Co., Cork, Republic of Ireland. peterakomo@validnutrition.org.
Alison W A TalbertKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. atalbert@kemri-wellcome.org.
Victoria M GossSouthampton National Institute of Health Research Respiratory Biomedical Research Unit, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. v.ledger@soton.ac.uk.
Moses NgariKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mngari@kemri-wellcome.org.
Johnstone ThitiriKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. jthitiri@kemri-wellcome.org.
Said NdoroKilifi County Hospital, Ministry of Health, Kilifi, 230-80108, Kenya. saidndoro@yahoo.com.
Miguel A Garcia KnightKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. miguel.garciaknight@ndm.ox.ac.uk.
Kenneth OmolloKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. oduorkenneth@gmail.com.
Anne NdunguKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. shiroann2001@gmail.com.
Musa M MulongoKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. mmulongo@kemri-wellcome.org.
Paluku BahwereValid International, 35 Leopold Street, Oxford, OX4 1TW, UK. paluku@validinternational.org.
Greg FeganKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. gfegan@kemri-wellcome.org.
John O WarnerCentre for Global Health Research and Section of Paediatrics, Imperial College, Norfolk Place, London, W2 1PG, UK. j.o.warner@imperial.ac.uk.
Anthony D PostleFaculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. a.d.postle@soton.ac.uk.
Steve CollinsValid Nutrition, Cuibín Farm, Derry Duff, Bantry, Co., Cork, Republic of Ireland. steve@validinternational.org.uk.
Philip C CalderFaculty of Medicine, University of Southampton, Southampton General Hosptial, Tremona Road, Southampton, SO16 6YD, UK. p.c.calder@soton.ac.uk.
James A BerkleyKEMRI-Wellcome Trust Research Programme, Kilifi, 230-80108, Kenya. jberkley@kemri-wellcome.org.
Kenya Medical Research Institute · KESouthampton General Hospital · GBAngkor Hospital for Children · KHValve (United States) · USImperial College London · GBMoving the GoalPosts · KEValid International (United Kingdom) · GB

Funding

Wellcome Trust 083579Wellcome Trust 092088Wellcome Trust 092654Wellcome Trust 093500
6 · The paper itself

Abstract

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.

Indexed as

Dietary SupplementsFast FoodsAcute DiseaseChild, PreschoolDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidFatty Acids, Omega-3Fatty Acids, UnsaturatedFemaleFish OilsHumansInfantKenyaLipidsMaleDocosahexaenoic AcidsEicosapentaenoic AcidFatty Acids, Omega-3Fatty Acids, UnsaturatedFish OilsLipids

Identifiers

PMID25902844
PMCPMC4407555
OpenAlexW2026060642

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.