Nonalcoholic Fatty LiverNCT03084328
Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
An observational study of Nonalcoholic Fatty Liver, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver
- What is being tested?
- Vitamind D
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2012to 10 Mar 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The study population for this study is patients who have fatty liver disease. Patients who have low vitamin D (<30ng/dL) and patients who have normal vitamin D (> or = to 30ng/dL) will be followed for six months and observed.
Who may be able to join
- Adults of age 18 or greater
- Diagnosis of fatty liver disease with a low Vitamin D level (< 30 ng/dl) in the past 6 months
- Able to give consent
Who cannot join
- Those currently receiving Vitamin D supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with Vitamin D replete status have lowering of Vitamin D over time if not supplemented.
One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will use this to follow patients as is currently done as standard of care. All patients in the Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. We hypothesize that patients with NAFLD with low Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.
- Conditions
- Nonalcoholic Fatty Liver
- Being tested
- Vitamind D
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamind DDietary supplement
Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with Vitamin D level of <30ng/dL | This is a cohort of patients with fatty liver disease and also have low levels of vitamin D Receives: Dietary Supplement: Vitamind D | |
| Patients with Vitamin D level of >30ng/dL | This is a cohort of patients with fatty liver disease and have normal levels of vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D levels
Change in plasma vitamin D levels from baseline to 6 months
Measured: Baseline and 6 months
Change in liver and renal function
Change in hepatic function panel and renal function panel from baseline to 6 months
Measured: Baseline and 6 months
Change in body composition data
Change in blood pressure, waist circumference, BIA and CT scan if performed clinically
Measured: Baseline and 6 months
Chang in lipid profile
Change in HDL, LDL, and TG from baseline to 6 months
Measured: Baseline and 6 months
Change in insulin resistance
Change in insulin resistance from baseline to 6 months
Measured: Basline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start20 Jan 2012
- Primary completion20 Dec 2014
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivasan Dasarathy, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084328
- Sponsor's protocol ID
- 13-00153
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03084328
- Acronym / sponsor ID
- 13-00153
- Conditions
- Nonalcoholic Fatty Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Jan 2012 (actual)
- Primary completion
- 20 Dec 2014 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 20 Mar 2017 (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.
Vitamin D deficiency is very common in patients with fatty liver disease as evidenced by our observations in the Metabolic Liver Clinic and that reported by others. We also observed that patients with more severe fatty liver disease had lower Vitamin D concentrations. Others have shown that replacing Vitamin D in patients with cirrhosis is effective and even patients with Vitamin D replete status have lowering of Vitamin D over time if not supplemented.
One of the measures of liver injury in NAFLD is the plasma concentration of ALT and we will use this to follow patients as is currently done as standard of care. All patients in the Metabolic Liver Clinic are being routinely screened for Vitamin D deficiency as standard of care and treatment is being started with oral supplementation, but there are not standardized protocols to determine success of therapy. We hypothesize that patients with NAFLD with low Vitamin D levels will respond appropriately to Vitamin D supplementation for 6 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Vitamin D level of <30ng/dL | – | Dietary Supplement: Vitamind DThis is a cohort of patients with fatty liver disease and also have low levels of vitamin D |
| Patients with Vitamin D level of >30ng/dL | – | –This is a cohort of patients with fatty liver disease and have normal levels of vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population for this study is patients who have fatty liver disease. Patients who have low vitamin D (<30ng/dL) and patients who have normal vitamin D (> or = to 30ng/dL) will be followed for six months and observed.
Key inclusion criteria (3 listed)
- Adults of age 18 or greater
- Diagnosis of fatty liver disease with a low Vitamin D level (< 30 ng/dl) in the past 6 months
- Able to give consent
Key exclusion criteria (1 listed)
- Those currently receiving Vitamin D supplementation
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 |
|---|---|---|
| Vitamind DPatients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months | Dietary supplement | Patients with Vitamin D level of <30ng/dL |
Primary outcome
Change in vitamin D levels
Time frame: Baseline and 6 months
Change in plasma vitamin D levels from baseline to 6 months
Change in liver and renal function
Time frame: Baseline and 6 months
Change in hepatic function panel and renal function panel from baseline to 6 months
Change in body composition data
Time frame: Baseline and 6 months
Change in blood pressure, waist circumference, BIA and CT scan if performed clinically
Chang in lipid profile
Time frame: Baseline and 6 months
Change in HDL, LDL, and TG from baseline to 6 months
Change in insulin resistance
Time frame: Basline and 6 months
Change in insulin resistance from baseline to 6 months
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 13 Apr 2017.
- Individual participant dataSharing planned: No. No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonalcoholic Fatty Liver, run by The Cleveland Clinic at 1 site in United States.
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 1 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in vitamin D levels (time frame: Baseline and 6 months). The study lists 5 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 13 Apr 2017.