Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

NCT ID: NCT03084328

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-20
• Study Completion Date: 2017-03-10

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Vitamind D

Intervention Type: 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

This is a cohort of patients with fatty liver disease and have normal levels of vitamin D

No interventions assigned to this group

Interventions

Vitamind D

Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Srinivasan Dasarathy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

13-00153

Identifier Type: -

Identifier Source: org_study_id