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Vitamin D in Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038853
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
University of Rijeka
Pliva Hrvatska d.o.o.
Information provided by (Responsible Party):
Ivana Mikolasevic, University Hospital Rijeka

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Vitamin D Deficiency Drug: 1,25-Dihydroxyvitamin D Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : April 1, 2019


Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038853


Sponsors and Collaborators
University Hospital Rijeka
University of Rijeka
Pliva Hrvatska d.o.o.
Investigators
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Principal Investigator: Ivana Mikolasevic, MD, PhD Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia

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Responsible Party: Ivana Mikolasevic, Asst. Prof., University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT04038853    
Other Study ID Numbers: 00000000-NAFLD
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Vitamin D Deficiency
Digestive System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Dihydroxycholecalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents