Evidence map›Paper›PMID 34092255›Full record

Trial reportNutrition journal2021

Effect of topical applications of sunflower seed oil on systemic fatty acid levels in under-two children under rehabilitation for severe acute malnutrition in Bangladesh: a randomized controlled trial.

K M Shahunja, Daniel C Sévin, Lindsay Kendall, Tahmeed Ahmed, Md Iqbal Hossain, Mustafa Mahfuz, Xinyi Zhu, Krishan Singh, Sunita Singh, Jonathan M Crowther and 2 more

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

Trial report in Nutrition journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02616289 (Topical Emollient Therapy in the Management of Severe Acute Malnutrition), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT02616289 nacompletednot on this map

Topical Emollient Therapy in the Management of Severe Acute Malnutrition: A Randomized Controlled Clinical Trial in Bangladesh

TypeinterventionalSponsorInternational Centre for Diarrhoeal Disease Research, BangladeshRan2016 to 2019Enrolled212ConditionsChild Malnutrition, Malnutrition in Children, MalnutritionArmsTopical emollient (Sun Flower seed oil)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 4 countries.

K M ShahunjaNutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Daniel C SévinCellzome GmbH, GlaxoSmithKline R&D, Meyerhofstrasse 1, 69117, Heidelberg, Germany.
Lindsay KendallGlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
Tahmeed AhmedNutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Md Iqbal HossainNutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Mustafa MahfuzNutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
Xinyi ZhuGlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
Krishan SinghGlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
Sunita SinghGlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
Jonathan M CrowtherJMC Scientific Consulting Ltd, Surrey, Egham, UK.
Rachel A GibsonGlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
Gary L DarmstadtDepartment of Pediatrics, Stanford University School of Medicine, 1701 Page Mill Road, Room 121, Palo Alto, Stanford, CA, 94304, USA. gdarmsta@stanford.edu.ORCID 0000-0002-7522-5824
GlaxoSmithKline (United Kingdom) · GBInternational Centre for Diarrhoeal Disease Research · BDGlaxoSmithKline (Germany) · DEStanford Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildren with severe acute malnutrition (SAM) have inadequate levels of fatty acids (FAs) and limited capacity for enteral nutritional rehabilitation. We hypothesized that topical high-linoleate sunflower seed oil (SSO) would be effective adjunctive treatment for children with SAM.

methodsThis study tested a prespecified secondary endpoint of a randomized, controlled, unblinded clinical trial with 212 children with SAM aged 2 to 24 months in two strata (2 to < 6 months, 6 to 24 months in a 1:2 ratio) at Dhaka Hospital of icddr,b, Bangladesh between January 2016 and December 2017. All children received standard-of-care management of SAM. Children randomized to the emollient group also received whole-body applications of 3 g/kg SSO three times daily for 10 days. We applied difference-in-difference analysis and unsupervised clustering analysis using t-distributed stochastic neighbor embedding (t-SNE) to visualize changes in FA levels in blood from day 0 to day 10 of children with SAM treated with emollient compared to no-emollient.

resultsEmollient therapy led to systematically higher increases in 26 of 29 FAs over time compared to the control. These effects were driven primarily by changes in younger subjects (27 of 29 FAs). Several FAs, especially those most abundant in SSO showed high-magnitude but non-significant incremental increases from day 0 to day 10 in the emollient group vs. the no-emollient group; for linoleic acid, a 237 μg/mL increase was attributable to enteral feeding and an incremental 98 μg/mL increase (41%) was due to emollient therapy. Behenic acid (22:0), gamma-linolenic acid (18:3n6), and eicosapentaenoic acid (20:5n3) were significantly increased in the younger age stratum; minimal changes were seen in the older children.

conclusionsSSO therapy for SAM augmented the impact of enteral feeding in increasing levels of several FAs in young children. Further research is warranted into optimizing this novel approach for nutritional rehabilitation of children with SAM, especially those < 6 months.

trial registrationClinicalTrials.gov : NCT02616289 .

Indexed as

Severe Acute MalnutritionAdolescentBangladeshChildChild, PreschoolEmollientsFatty AcidsHumansInfantSunflower OilEmollientsFatty AcidsSunflower OilBangladeshChildrenEmollientFatty acidsMalnutritionSunflower seed oilTopical application

Identifiers

PMID34092255
PMCPMC8183055
OpenAlexW3167622331

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.