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Treatment of non-alcoholic steatohepatitis patients with vitamin D: a double-blinded, randomized, placebo-controlled pilot study.
- Source :
-
Scandinavian journal of gastroenterology [Scand J Gastroenterol] 2018 Sep; Vol. 53 (9), pp. 1114-1120. Date of Electronic Publication: 2018 Sep 29. - Publication Year :
- 2018
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Adult
Double-Blind Method
Female
Humans
Liver pathology
Male
Middle Aged
Non-alcoholic Fatty Liver Disease pathology
Pilot Projects
Severity of Illness Index
Switzerland
Treatment Outcome
Vitamin D Deficiency blood
Young Adult
Alanine Transaminase blood
Calcifediol administration & dosage
Non-alcoholic Fatty Liver Disease blood
Non-alcoholic Fatty Liver Disease drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1502-7708
- Volume :
- 53
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Scandinavian journal of gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 30270688
- Full Text :
- https://doi.org/10.1080/00365521.2018.1501091