1. Treatment of non-alcoholic steatohepatitis patients with vitamin D: a double-blinded, randomized, placebo-controlled pilot study.
- Author
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Geier A, Eichinger M, Stirnimann G, Semela D, Tay F, Seifert B, Tschopp O, Bantel H, Jahn D, Marques Maggio E, Saleh L, Bischoff-Ferrari HA, Müllhaupt B, and Dufour JF
- 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
- 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., 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.
- Published
- 2018
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