Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Clinical Trial

Official title:

Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084328
• Other study ID #: 13-00153
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: April 12, 2017
• Start date: January 20, 2012
• Est. completion date: March 10, 2017

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 10, 2017
• Est. primary completion date: December 20, 2014
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

Intervention

Dietary Supplement:
• Vitamind D
Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

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