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

BMC Medicine

Research Article

Francesco Angelico¹  Ludovica Perri¹  Maria Del Ben¹  Flavia Agata Cimini¹  Maria Gisella Cavallo¹  Ilaria Barchetta¹  Antonio Fraioli¹  Rosella Saulle²  Giuseppe La Torre²  Carlo Catalano³  Michele Di Martino³  Laura Bertoccini⁴  Claudio Tiberti⁴  Francesca Panimolle⁴  Marco Giorgio Baroni⁵  Sergio Morini⁶ 

[1] Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Viale del Policlinico 155, 00161, Rome, Italy;Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy;Department of Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy;Endocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy;Endocrinology and Diabetes, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy;Department of Medical Sciences, Endocrinology and Diabetes, University of Cagliari, Cagliari, Italy;Microscopic and Ultrastructural Anatomy (CIR), University Campus Bio-Medico, Rome, Italy;

关键词: Fatty liver;    NAFLD;    Vitamin D supplementation;    Type 2 diabetes;   

DOI  :  10.1186/s12916-016-0638-y

 received in 2016-03-14, accepted in 2016-06-09,  发布年份 2016

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2016