Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

April 12, 2017 updated by: Srinivasan Dasarathy, The Cleveland Clinic

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

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

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

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

This is where you will find people and organizations involved with this study.

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)

January 20, 2012

Primary Completion (Actual)

December 20, 2014

Study Completion (Actual)

March 10, 2017

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

March 14, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared

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.

Yes

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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