Vitamin D supplementation in patients with fatty liver and vitamin D deficiency

Not Applicable

• Conditions: K76.0; Fatty (change of) liver, not elsewhere classified

• Registration Number: DRKS00007816
• Lead Sponsor: Saarland University Medical Center Department of Internal Medicine II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-16
• Study Completion: 2016-09-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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

severe hepatic encephalopathy (CFF <35 Hz)
- Interferon treatment
- hypercalcaemia (>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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Improvements in the following parameters after 4 weeks, 3 and 6 months of vitamin D supplementation: <br><br>- Fibrosis as assessed using the transient elastography (Fibroscan) <br>- Liver function tests (ALT, AST, AP, GGT, Bilirubin, Albumin)