Vitamin D in Fatty Liver Disease

July 28, 2019 updated by: Ivana Mikolasevic, University Hospital Rijeka

Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography

This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo

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

In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, or family physicians in the Department of Gastroenterology CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 450 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving original medication during the 12 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 12 months period, which will be identical to the original medication in its packaging and form.

After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of NAFLD.

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.
360

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 4

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
  • signed informed consent
  • possibility to follow instruction and the protocol

Exclusion Criteria:

  • chronic B or C hepatitis
  • usage of hepatotoxic drugs in the period of 6 months before inclusion
  • chronic kidney insufficiency (grade 4 and 5), hemodialysis
  • any other chronic liver disease
  • opioid dependancy
  • any malignancy
  • HIV seropositivity
  • alcohol abuse
  • pregnancy
  • inability to follow the protocol

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: Quadruple

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.
Experimental: Vitamin D
Intervention drug, containing 1,25-dihydroxy-vitamin D, comes in original packages as vials containing a total amount of 10 ml of clear solution. 5 drops accounting for 1000 IU of 1,25-dihydroxy-vitamin D will be administered orally on a daily basis.
Drug: 1,25-Dihydroxyvitamin D
1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months
Other Names:
  • 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3
Placebo Comparator: Placebo
A placebo identical to the study intervention drug in all its characteristics (package, visual characteristics of the fluid, smell, and taste) will be administered in the same manner.
Drug: Placebo
Placebo identical to the study intervention drug

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
Measure Description
Time Frame
Elastographic parameter of steatosis
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Elastographic parameter of fibrosis
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period
Week 0 - initiation; after 6 months; and after 12 months (end of study)

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
Aspartate transaminase
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in liver enzyme aspartate transaminase (AST) serum levels in the period of 6 and 12 months. Normal range = 11-38 IU/L.
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Alanine transaminase
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in liver enzyme alanine transaminase (ALT) serum levels in the period of 6 and 12 months. Normal range = 12-48 IU/L.
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Gamma-glutamyl transferase
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in liver enzyme gamma-glutamyl transferase (GGT) serum levels in the period of 6 and 12 months. Normal range = 11-55 IU/L.
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Insuline Resistance
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in insulin resistance defined by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; normal range = 0.5 to 1.4) score in the period of 6 and 12 months
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Total cholesterol
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in total cholesterol serum levels in the period of 6 and 12 months
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Low-density lipoprotein
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in low-density lipoprotein (LDL) serum levels in the period of 6 and 12 months
Week 0 - initiation; after 6 months; and after 12 months (end of study)
High-density lipoprotein
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in high-density lipoprotein (HDL) serum levels in the period of 6 and 12 months
Week 0 - initiation; after 6 months; and after 12 months (end of study)
Triglyceride
Time Frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Change in triglyceride (TG) serum levels in the period of 6 and 12 months
Week 0 - initiation; after 6 months; and after 12 months (end of study)

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.
University Hospital Rijeka

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Rijeka
Pliva Hrvatska d.o.o.

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: Ivana Mikolasevic, MD, PhD, Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia

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 (Actual)

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, 2015

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.
February 1, 2017

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.
April 1, 2019

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).
July 22, 2019

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.
July 28, 2019

First Posted (Actual)

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.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

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.
July 31, 2019

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.
July 28, 2019

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.
July 1, 2019

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.
  • 00000000-NAFLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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