Non-alcoholic Fatty Liver DiseasePhase 4NCT04038853
Vitamin D in Fatty Liver Disease
A Phase 4 study testing 1,25-Dihydroxyvitamin D in people with Non-alcoholic Fatty Liver Disease and Vitamin D Deficiency, run by University Hospital Rijeka.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Vitamin D Deficiency
- What is being tested?
- 1,25-Dihydroxyvitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 1 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
- signed informed consent
- possibility to follow instruction and the protocol
Who cannot join
- 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
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- HIV seropositivity
- alcohol abuse
- pregnancy
- inability to follow the protocol
About this study
Official title: 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
Read the 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.
- Being tested
- 1,25-Dihydroxyvitamin D, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,25-Dihydroxyvitamin DDrug
Also called 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D3
1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months
PlaceboDrug
Placebo identical to the study intervention drug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 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. Receives: Drug: 1,25-Dihydroxyvitamin D |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastographic parameter of steatosis
Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Elastographic parameter of fibrosis
Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Secondary outcomes (8)
Aspartate transaminase
Change in liver enzyme aspartate transaminase (AST) serum levels in the period of 6 and 12 months. Normal range = 11-38 IU/L.
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Alanine transaminase
Change in liver enzyme alanine transaminase (ALT) serum levels in the period of 6 and 12 months. Normal range = 12-48 IU/L.
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Gamma-glutamyl transferase
Change in liver enzyme gamma-glutamyl transferase (GGT) serum levels in the period of 6 and 12 months. Normal range = 11-55 IU/L.
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Insuline Resistance
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
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Total cholesterol
Change in total cholesterol serum levels in the period of 6 and 12 months
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Low-density lipoprotein
Change in low-density lipoprotein (LDL) serum levels in the period of 6 and 12 months
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
High-density lipoprotein
Change in high-density lipoprotein (HDL) serum levels in the period of 6 and 12 months
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Triglyceride
Change in triglyceride (TG) serum levels in the period of 6 and 12 months
Measured: Week 0 - initiation; after 6 months; and after 12 months (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Dec 2015
- Primary completion1 Feb 2017
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Rijeka
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rijeka, Pliva Hrvatska d.o.o.
- Responsible party
- Principal investigator, Ivana Mikolasevic, University Hospital Rijeka
- Investigators
- Ivana Mikolasevic, MD, PhD, Principal investigator, Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038853
- Sponsor's protocol ID
- 00000000-NAFLD
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography
- ClinicalTrials.gov ID
- NCT04038853
- Acronym / sponsor ID
- 00000000-NAFLD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University Hospital RijekaUniversity, hospital or other
- Collaborators
- University of Rijeka, Pliva Hrvatska d.o.o.
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: 1,25-Dihydroxyvitamin DIntervention 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. |
| Placebo | Placebo comparator | Drug: PlaceboA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
- signed informed consent
- possibility to follow instruction and the protocol
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1,25-Dihydroxyvitamin DAlso: 1,25-Dihydroxy-Cholecalciferol, Cholecalciferol, Vitamin D31,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months | Drug | Vitamin D |
| PlaceboPlacebo identical to the study intervention drug | Drug | Placebo |
Primary outcome
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
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
8 secondary outcomes
Aspartate transaminase
Time frame: 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)
Gamma-glutamyl transferase
Time frame: 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)
Total cholesterol
Time frame: 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)
High-density lipoprotein
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivana Mikolasevic, MD, PhD principal investigator
Department of Gastroenterology, Clinical Hospital Center Rijeka, University of Rijeka, Croatia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1,25-Dihydroxyvitamin D in people with Non-alcoholic Fatty Liver Disease and Vitamin D Deficiency, run by University Hospital Rijeka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastographic parameter of steatosis (time frame: Week 0 - initiation; after 6 months; and after 12 months (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.