A randomized, double-blind, placebo controlled clinical trial to find out the approbiate daily oral dose of vitamin D in patients with liver cirrhosis.

Phase 1

• Conditions: decompensated and compensated liver cirrhosis; MedDRA version: 16.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-001449-42-AT
• Lead Sponsor: Medizinische Universität Graz, Kl. Abt. f. Endokrinoloie u. Stoffwechsel & Kl. Abt. f. Gastroenterologie u. Hepatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
• Compensated and decompensated cirrhosis diagnosed by the hepatologist for at last three months previous study baseline
• Age of = 18 years
• Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

Hypercalcemia defined a serum calcium >2.65 mmol/L
• Pregnancy or lactating women
• Drug intake as part of another clinical study
• Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
• Any disease with an estimated life expectancy below 1 year
• Any clinically significant acute disease requiring drug treatment
• Chemotherapy or radiation therapy during the study
• Regular intake of more than 880 International Units (IU) vitamin D in the last twelve weeks before study entry or during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our main objective is to evaluate whether vitamin D supplementation with 2,800 IU daily over 8 weeks significantly increase vitamin D levels when compared to placebo. ;Secondary Objective: Testing of the hypotheses that vitamin D supplementation improves liver function parameters.;Primary end point(s): serum 25(OH) Vitamin D;Timepoint(s) of evaluation of this end point: at visit 1,2,3,4,5

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): liver synthesis parameters: albumin, INR, bilirubin<br>• abdominal ultrasound: ascites<br>• cerebral cognitive functions ( classified after hepatic encephalopathy 0 - IV)<br>• renal functions: creatinine, GFR<br>• ammonia<br>;Timepoint(s) of evaluation of this end point: at visit 1,2,3,4,5