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

A randomized, double-blind, placebo controlled trial to evaluate vitamin D supplementation on serum 25 hydroxy- vitamin D level in cirrhotic patients - VIT D Cirr

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001449-42-AT

Enrollment

100

Registered

2014-01-16

Start date

2014-10-03

Completion date

Unknown

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

decompensated and compensated liver cirrhosis MedDRA version: 16.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 100000004871

Interventions

Trade Name: Oleovit D3 Tropfen Pharmaceutical Form: Oral solution INN or Proposed INN: Colecalciferol CAS Number: 67-97-0 Other descriptive name: COLECALCIFEROL CONCENTRATE (OILY FORM) Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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

Countries

Austria

Contacts

Public ContactLeberambulanz

Medizinische Universität Graz, Kl. Abt. f. Gastroenterologie u. Hepatologie

csilla.putz-bankuti@medunigraz.at43316385 12731

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026