Vitamin D Supplementation in Cirrhotic Patients

June 3, 2015 updated by: Rudolf Stauber, MD, Medical University of Graz

Vitamin D Supplementation in Cirrhotic Patients: A Randomized, Multi-center, Double-blind, Placebo Controlled Trial to Evaluate Vitamin D Supplementation on Serum 25-hydroxyvitamin D Levels in Cirrhotic Patients

Previous studies suggested that vitamin D deficiency is highly prevalent in cirrhotic patients and is related to the degree of liver dysfunction as well as mortality. In gastrointestinal disorders, vitamin D absorption can be highly reduced.

We herein aim to investigate the efficacy of oral vitamin D supplementation in cirrhotic patients with vitamin D insufficiency.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cirrhosis of the liver is a slowly progressive disease with a high number of complications like hepatic encephalopathy, gastrointestinal bleeding, ascites, renal failure and hepatocellular cancer leading to death. Cirrhosis as a cause of death has increased progressively in the mortality data for the general population.

This terminal liver disease as a complication of chronic viral hepatitis, alcoholism and metabolic disorders, with genetic and non-genetic predisposition, may be linked to nutritional aberration as a precursor to or an effect of the illness. Previous studies suggested that chronic liver diseases may be related to high prevalence of vitamin D deficiency and in gastrointestinal disorders the vitamin D absorption can be highly reduced.

Patients with cirrhosis are often presented with malnutrition and one of the limiting factors of the intestinal malabsorption is the portal hypertension due to the liver disease. Beside nutrition the main source of vitamin D is sunlight and ultraviolet-B inducing the conversion of 7-dehydrocholesterol to vitamin D in the skin; therefore limited sunlight exposure of the skin may lead to an inadequate vitamin D status.

Vitamin D itself is biologically inactive and has to be hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D) as the main circulating metabolite used for classification of the vitamin D status. 1,25 hydroxyvitamin D (1,25(OH)D) is produced through conversion by the enzyme 1-alpha-hydroxylase in the kidney. This vitamin D metabolite shows a higher affinity for the vitamin D receptor (VDR) compared to 25(OH)D. After binding and activation of the VDR three percent of the human genome will be regulated. Among the main role of vitamin D metabolites to regulate calcium and bone homeostasis, they also show non-skeletal effects with relevance in the development of several chronic diseases. In this context, vitamin D deficiency has been associated with an increased risk of cancer , cardiovascular, autoimmune, and infectious diseases, Based on these findings, a significantly reduced risk of mortality was shown in patients with oral vitamin D supplementation in randomized controlled studies.

Our previously published study presented a prospective association of vitamin D levels with occurrence of hepatic decompensation. Furthermore vitamin D deficiency was associated with high mortality in cirrhotic patients dependent on liver dysfunction. Concerning this aspect the main point is to investigate in this study whether low vitamin D status is the consequence of increasing deterioration of the liver synthesis or may even contribute to liver dysfunction. Low synthesis of vitamin D in the skin can be the result of reduced sunlight exposure and malnutrition and/or malabsorption in cirrhotic patients. On the other hand, organ dysfunction may impair the activity of 25-hydroxylase in the liver. Despite the above mentioned correlation between vitamin D deficiency and liver dysfunction there is still insufficient evidence to recommend oral vitamin D supplementation as a concomitant therapy in clinical practice because there exists no adequately designed randomized controlled trial that evaluates the necessary daily oral dose on vitamin D.

We aim to address this issue in the present study so that the findings of our study will lead to implementation of treatment strategies for maintaining a sufficient vitamin D status in cirrhotic patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Gratwein, Styria, Austria, 8112
        • Department of Internal Medicine, LKH Hoergas
      • Graz, Styria, Austria, 8036
        • Department of Internal Medicine, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 prior to study start
  • Age between 18 and 75 years
  • Written informed consent
  • Negative pregnancy test in women of childbearing potential

Exclusion Criteria:

  • Hypercalcemia defined as total serum calcium >2.65 mmol/L
  • Pregnancy or lactating women
  • Drug intake as part of another clinical study
  • Glomerular filtration rate (GFR) < 15 ml/min/1.73m²
  • Any disease with an estimated life expectancy below 1 year
  • Any clinically significant acute disease requiring drug treatment
  • Anticipated chemotherapy or radiation therapy during the study
  • Regular intake of more than 800 International Units (IU) of vitamin D during the last 4 weeks before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vitamin D supplementation
Colecalciferol 2.800 IU/day
Dietary supplement: Vitamin D supplementation
oral administration of colecalciferol 2.800 IU once daily
Placebo Comparator: Placebo
Vehicle (coconut oil)
Dietary supplement: Placebo
oral administration of placebo (vehicle) once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
serum 25(OH)D
Time Frame: 8 weeks after study start
8 weeks after study start

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver function tests
Time Frame: 8 weeks after study start
Albumin, prothrombin time, bilirubin
8 weeks after study start
Hyaluronic acid
Time Frame: 8 weeks after study start
8 weeks after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Graz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rudolf E Stauber, MD, Dept of Internal Medicine, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VITDZIRR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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