Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

Completed

• Conditions: Nonalcoholic Fatty Liver
• Interventions: Dietary Supplement: Vitamind D

• Registration Number: NCT03084328
• Lead Sponsor: The Cleveland Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-20
• Primary Completion: 2014-12-20
• Study Completion: 2017-03-10
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-20
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Vitamin D level of <30ng/dL	Vitamind D	This is a cohort of patients with fatty liver disease and also have low levels of vitamin D

Primary Outcome Measures

Name	Time	Method
Change in vitamin D levels	Baseline and 6 months	Change in plasma vitamin D levels from baseline to 6 months
Change in liver and renal function	Baseline and 6 months	Change in hepatic function panel and renal function panel from baseline to 6 months
Change in body composition data	Baseline and 6 months	Change in blood pressure, waist circumference, BIA and CT scan if performed clinically
Change in insulin resistance	Basline and 6 months	Change in insulin resistance from baseline to 6 months
Chang in lipid profile	Baseline and 6 months	Change in HDL, LDL, and TG from baseline to 6 months

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States