Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

Completed

Conditions studied: Nonalcoholic Fatty Liver

In brief

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.

Key facts

Study ID

NCT03084328

Run by

The Cleveland Clinic

People needed

48

Starts

2012-01-20

Expected to finish

2017-03-10

Last updated by the study team

2017-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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