Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

NCT03084328 | Completed

• 1 other identifier: 13-00153
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (5)

• Change in vitamin D levels

  Change in plasma vitamin D levels from baseline to 6 months

  Baseline and 6 months

• Change in liver and renal function

  Change in hepatic function panel and renal function panel from baseline to 6 months

  Baseline and 6 months

• Change in body composition data

  Change in blood pressure, waist circumference, BIA and CT scan if performed clinically

  Baseline and 6 months

• Chang in lipid profile

  Change in HDL, LDL, and TG from baseline to 6 months

  Baseline and 6 months

• Change in insulin resistance

  Change in insulin resistance from baseline to 6 months

  Basline and 6 months

Study Arms (2)

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

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

Interventions

Vitamind D DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Those currently receiving Vitamin D supplementation

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: January 20, 2012
• Primary Completion: December 20, 2014
• Study Completion: March 10, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)