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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamind D | Dietary Supplement | Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D levels | Change in plasma vitamin D levels from baseline to 6 months | Baseline and 6 months |
| Change in liver and renal function | Change in hepatic function panel and renal function panel from baseline to 6 months | Baseline and 6 months |
| Change in body composition data | Change in blood pressure, waist circumference, BIA and CT scan if performed clinically | Baseline and 6 months |
| Chang in lipid profile | Change in HDL, LDL, and TG from baseline to 6 months | Baseline and 6 months |
| Change in insulin resistance | Change in insulin resistance from baseline to 6 months | Basline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population for this study is patients who have fatty liver disease. Patients who have low vitamin D (<30ng/dL) and patients who have normal vitamin D (> or = to 30ng/dL) will be followed for six months and observed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
No plan to share data, needs HIPPA clearance and specific IRB approval, we did not plan on original data being shared
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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