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
Full text not available from this repository.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: |
05 Dec 2022 15:18 |
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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