Vitamin D Supplementation in Cirrhotic Patients
1 other identifier
interventional
36
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2013
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 4, 2015
June 1, 2015
8 months
December 9, 2013
June 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
serum 25(OH)D
8 weeks after study start
Secondary Outcomes (2)
Liver function tests
8 weeks after study start
Hyaluronic acid
8 weeks after study start
Study Arms (2)
Vitamin D supplementation
ACTIVE COMPARATORColecalciferol 2.800 IU/day
Placebo
PLACEBO COMPARATORVehicle (coconut oil)
Interventions
oral administration of colecalciferol 2.800 IU once daily
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Internal Medicine, LKH Hoergas
Gratwein, Styria, 8112, Austria
Department of Internal Medicine, Medical University of Graz
Graz, Styria, 8036, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rudolf E Stauber, MD
Dept of Internal Medicine, Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ. Prof. Dr. med.
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
December 1, 2013
Primary Completion
August 1, 2014
Study Completion
June 1, 2015
Last Updated
June 4, 2015
Record last verified: 2015-06