K76.0
Conditions
Interventions
Group 1: Vitamin D supplementation (20000 IU Dekristol p.o. daily for the first 7 days, thereon weekly) for 6 months
Sponsors
Saarland University Medical Center Department of Internal Medicine II
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Men and Women >18 years - Patients with hepatic steatosis (>280 dB/m using CAP) - Patients with vitamin D deficiency (serum 25-hydroxyvitamin D <20 ng/ml)
Exclusion criteria
Exclusion criteria: severe hepatic encephalopathy (CFF 2.7 mmol/l) or hypercalciuria (>8.0 mmol/d) with or without hyperparathyroidism (>65.0 pg/ml) - history of calcium-containing kidney stones - allergy or hypersensitivity to any of the supplement ingredients: peanuts, soy, gelatin - sarcoidosis - stage IV or V Chronic Kidney Disease - Pregnancy - Liver cirrhosis (Fibroscan, TE >13kPa) - Alcohol consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes (reductions) in hepatic steatosis, as assessed using controlled attenuation parameter (CAP) after 4 weeks and 3 and 6 months of vitamin D suppplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in the following parameters after 4 weeks, 3 and 6 months of vitamin D supplementation: - Fibrosis as assessed using the transient elastography (Fibroscan) - Liver function tests (ALT, AST, AP, GGT, Bilirubin, Albumin) | — |
Countries
Germany
Contacts
Public ContactCaroline Stokes
Saarland University Medical Center
Outcome results
None listed