Evidence map›Paper›PMID 27977757›Full record

Trial reportPloS one2016

Docosahexanoic Acid Plus Vitamin D Treatment Improves Features of NAFLD in Children with Serum Vitamin D Deficiency: Results from a Single Centre Trial.

Claudia Della Corte, Guido Carpino, Rita De Vito, Cristiano De Stefanis, Anna Alisi, Stefano Cianfarani, Diletta Overi, Antonella Mosca, Laura Stronati, Salvatore Cucchiara and 4 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 6 pooled it
10.0field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 6 syntheses or guidelines pooled it, 106 citations in OpenAlex.

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  7. The effects of fish oil plus vitamin DEuropean journal of nutrition · 2022
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  14. The combined pioglitazone and topiramate therapy for management of pediatric patients with severe MASLD.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024
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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

14 authors at 8 institutions in 4 countries.

Claudia Della CorteHepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Guido CarpinoDepartment of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome "Foro Italico"- Rome, Italy.
Rita De VitoHistopathology Unit, "Bambino Gesù" Children's Hospital, IRCCS- Rome, Italy.
Cristiano De StefanisLiver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Anna AlisiLiver Research Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Stefano CianfaraniEndocrinology and Diabetes Unit, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Diletta OveriDepartment of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome-Rome, Italy.
Antonella MoscaHepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Laura StronatiDepartment of Cellular Biotechnology and Hematology, Sapienza University Hospital Umberto I, Rome, Italy.
Salvatore CucchiaraDepartment of Pediatrics, Pediatric Gastroenterology and Liver Unit, Sapienza University Hospital Umberto I, Rome, Italy.
Massimiliano RaponiMedical Directorate, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Eugenio GaudioDepartment of Anatomical, Histological, Forensic Medicine and Orthopedics Sciences, Sapienza University of Rome-Rome, Italy.
Christopher D ByrneHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton-, Southampton, United Kingdom.
Valerio NobiliHepato-Metabolic Department, "Bambino Gesù" Children's Hospital, IRCCS-Rome, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITPoliclinico Umberto I · ITSapienza University of Rome · ITBambino Gesù Children's Hospital · ITDiabetes Australia · AUDirectorate of Health · ISForo Italico University of Rome · ITUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are no licensed treatments for non alcoholic fatty liver disease (NAFLD) in adults or children. In NAFLD, several studies have shown a benefit of omega-3 fatty acid treatment on lipid profile, insulin-sensitivity and hepatic steatosis and it has also been suggested that Vitamin D treatment has potential antifibrotic properties in liver disease. TRIAL

designTo date, however, there are no studies that have tested the combination of Docosahexanoic acid (DHA) and vitamin D treatment which may benefit the whole spectrum of disease in NAFLD. Our aim therefore, was to test the effect of daily DHA (500 mg) plus vitamin D (800 IU) treatment, in obese children with biopsy-proven NAFLD and vitamin D deficiency, in a randomized, double-blind placebo-controlled trial.

methodsThe 41/43 patients completed the study (18-treatment, 23-placebo). At 12 months: i) the main outcome was liver histology improvement, defined by NAS; ii) the secondary outcome was amelioration of metabolic parameters.

resultsDHA plus vitamin D treatment reduced the NAFLD Activity Score (NAS), in the treatment group (5.4 v1.92; p<0.001 for baseline versus end of study). There was no change in fibrosis score, but a reduction of the activation of hepatic stellate cells (HSC) and fibrillar collagen content was noted (3.51±1.66 v. 1.59±1.37; p = 0.003) in treatment group. Moreover, the triglycerides (174.5 vs. 102.15 mg/dl), ALT (40.25 vs. 24.5 UI/l) and HOMA-IR (4.59 vs. 3.42) were all decreased with treatment.

conclusionDHA plus vitamin D treatment improved insulin-resistance, lipid profile, ALT and NAS. There was also decreased HSC activation and collagen content with treatment.

Indexed as

AdolescentChildChild, PreschoolDocosahexaenoic AcidsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLiverMaleNon-alcoholic Fatty Liver DiseaseTreatment OutcomeVitamin DVitamin D DeficiencyDocosahexaenoic AcidsVitamin D

Identifiers

PMID27977757
PMCPMC5158039
OpenAlexW2561567615

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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.