Treatment of non-alcoholic steatohepatitis patients with vitamin D: a double-blinded, randomized, placebo-controlled pilot study.

Geier, Andreas; Eichinger, Mareile; Stirnimann, Guido; Semela, David; Tay, Fabian; Seifert, Burkhardt; Tschopp, Oliver; Bantel, Heike; Jahn, Daniel; Marques Maggio, Ewerton; Saleh, Lanja; Bischoff-Ferrari, Heike A; Müllhaupt, Beat; Dufour, Jean-François (2018). Treatment of non-alcoholic steatohepatitis patients with vitamin D: a double-blinded, randomized, placebo-controlled pilot study. Scandinavian journal of gastroenterology, 53(9), pp. 1114-1120. Taylor & Francis 10.1080/00365521.2018.1501091

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BACKGROUND Non-alcoholic steatohepatitis (NASH) is defined by liver inflammation and consecutive fibrotic damage caused by a deposition of fat in the liver. No licensed medical treatments exist and lifestyle modification is difficult to incorporate into everyday life. We investigated the efficacy and safety of a 48-week treatment with vitamin D3 in NASH patients. METHODS Histologically determined NASH patients with elevated alanine aminotransferase (ALT) and decreased 25-OH vitamin D level at baseline received vitamin D3 or placebo orally over a 48-week period. The primary endpoint of this study was the change in ALT from baseline to the end-of-treatment. Steatohepatitis was categorized according to the Steatosis, Activity and Fibrosis Score and disease activity was assessed using the NAFLD activity score. RESULTS Serum 25-OH vitamin D levels significantly increased only in the vitamin D3 group over the 48-week treatment phase indicating compliance. In contrast to placebo, patients in the vitamin D group had markedly decreased ALT levels after the end-of-treatment phase. A significant decrease during treatment with vitamin D was also observed for cytokeratin-18 fragments compared with placebo. The study was not powered to detect changes in histological score, hence only descriptive results for histopathological characteristics are available. CONCLUSIONS Treatment with 2100 IE vitamin D q.d. over 48 weeks was well tolerated and led to a significant improvement of serum ALT levels in patients with hypovitaminosis D and histology-proven NASH as the primary endpoint together with a trend toward reduction of hepatic steatosis, which was not significant due to a small number of available biopsy specimens.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology

UniBE Contributor:

Stirnimann, Guido

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0036-5521

Publisher:

Taylor & Francis

Language:

English

Submitter:

Thi Thao Anh Pham

Date Deposited:

11 Dec 2018 16:05

Last Modified:

11 Dec 2018 16:05

Publisher DOI:

10.1080/00365521.2018.1501091

PubMed ID:

30270688

Uncontrolled Keywords:

NAFLD NASH drug therapy vitamin D

URI:

https://boris.unibe.ch/id/eprint/120315

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