Evidence map›Paper›PMID 27353492›Full record

Trial reportBMC medicine2016

No effects of oral vitamin D supplementation on non-alcoholic fatty liver disease in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial.

Ilaria Barchetta, Maria Del Ben, Francesco Angelico, Michele Di Martino, Antonio Fraioli, Giuseppe La Torre, Rosella Saulle, Ludovica Perri, Sergio Morini, Claudio Tiberti and 6 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 18 pooled it
14.1field-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

90 citing papers in PubMed, 18 syntheses or guidelines pooled it, 182 citations in OpenAlex.

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  11. Vitamin D supplementation for chronic liver diseases in adults.The Cochrane database of systematic reviews · 2021
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  17. Vitamin D supplementation for chronic liver diseases in adults.The Cochrane database of systematic reviews · 2017
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  20. The effects of fish oil plus vitamin DEuropean journal of nutrition · 2022
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30 more citing papers are in PubMed but not listed here.

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

16 authors at 3 institutions in 1 country.

Ilaria BarchettaDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Maria Del BenDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Francesco AngelicoDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Michele Di MartinoDepartment of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
Antonio FraioliDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Giuseppe La TorreDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Rosella SaulleDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Ludovica PerriDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Sergio MoriniMicroscopic and Ultrastructural Anatomy (CIR), University Campus Bio-Medico, Rome, Italy.
Claudio TibertiEndocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Laura BertocciniEndocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Flavia Agata CiminiDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy.
Francesca PanimolleEndocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Carlo CatalanoDepartment of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy.
Marco Giorgio BaroniEndocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Maria Gisella CavalloDepartment of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy. gisella.cavallo@uniroma1.it.
Sapienza University of Rome · ITPoliclinico Umberto I · ITUniversità Campus Bio-Medico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-alcoholic fatty liver disease (NAFLD) is the most common hepatic disorder worldwide, reaching prevalence up to 90 % in obese patients with type 2 diabetes (T2D), and representing an independent risk factor for cardiovascular mortality. Furthermore, the coexistence of T2D and NAFLD leads to higher incidence of diabetes' complications and additive detrimental liver outcomes. The existence of a close association between NAFLD and hypovitaminosis D, along with the anti-inflammatory and insulin-sensitizing properties of vitamin D, have been largely described, but vitamin D effects on hepatic fat content have never been tested in a randomized controlled trial. We assessed the efficacy and safety of 24-week oral high-dose vitamin D supplementation in T2D patients with NAFLD.

methodsThis randomized, double-blind, placebo-controlled trial was carried out at the Diabetes Centre of Sapienza University, Rome, Italy, to assess oral treatment with cholecalciferol (2000 IU/day) or placebo in T2D patients with NAFLD. The primary endpoint was reduction of hepatic fat fraction (HFF) measured by magnetic resonance; as hepatic outcomes, we also investigated changes in serum transaminases, CK18-M30, N-terminal Procollagen III Propeptide (P3NP) levels, and Fatty Liver Index (FLI). Secondary endpoints were improvement in metabolic (fasting glycaemia, HbA1c, lipids, HOMA-IR, HOMA-β, ADIPO-IR, body fat distribution) and cardiovascular (ankle-brachial index, intima-media thickness, flow-mediated dilatation) parameters from baseline to end of treatment.

resultsSixty-five patients were randomized, 26 (cholecalciferol) and 29 (placebo) subjects completed the study. 25(OH) vitamin D significantly increased in the active treated group (48.15 ± 23.7 to 89.80 ± 23.6 nmol/L, P < 0.001); however, no group differences were found in HFF, transaminases, CK18-M30, P3NP levels or FLI after 24 weeks. Vitamin D neither changed the metabolic profile nor the cardiovascular parameters.

conclusionsOral high-dose vitamin D supplementation over 24 weeks did not improve hepatic steatosis or metabolic/cardiovascular parameters in T2D patients with NAFLD. Studies with a longer intervention period are warranted for exploring the effect of long time exposure to vitamin D.

trial registrationThis trial was approved on July 2011 by the Ethics Committee of Policlinico Umberto I, Sapienza University of Rome, Italy, and registered at www.clinicaltrialsregister.eu number 2011-003010-17.

Indexed as

Dietary SupplementsAdministration, OralCholecalciferolDiabetes Mellitus, Type 2Double-Blind MethodFemaleHumansItalyMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseRisk FactorsCholecalciferolFatty liverNAFLDType 2 diabetesVitamin D supplementation

Identifiers

PMID27353492
PMCPMC4926287
OpenAlexW2429102024

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.