Nonalcoholic Fatty Liver
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamind D
Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months
Sponsors
The Cleveland Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Chang in lipid profile | Baseline and 6 months | Change in HDL, LDL, and TG from baseline to 6 months |
| Change in insulin resistance | Basline and 6 months | Change in insulin resistance from baseline to 6 months |
Countries
United States
Outcome results
None listed