- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03084328
Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Those currently receiving Vitamin D supplementation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vitamin D levels
Time Frame: Baseline and 6 months
|
Change in plasma vitamin D levels from baseline to 6 months
|
Baseline and 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
|
Baseline and 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
|
Baseline and 6 months
|
Chang in lipid profile
Time Frame: Baseline and 6 months
|
Change in HDL, LDL, and TG from baseline to 6 months
|
Baseline and 6 months
|
Change in insulin resistance
Time Frame: Basline and 6 months
|
Change in insulin resistance from baseline to 6 months
|
Basline and 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-00153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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