Vitamin D Replacement in Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in vitamin D levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Those currently receiving Vitamin D supplementation
结局指标
主要结局
Change in vitamin D levels
时间窗: Baseline and 6 months
Change in plasma vitamin D levels from baseline to 6 months
Change in liver and renal function
时间窗: Baseline and 6 months
Change in hepatic function panel and renal function panel from baseline to 6 months
Change in body composition data
时间窗: Baseline and 6 months
Change in blood pressure, waist circumference, BIA and CT scan if performed clinically
Change in insulin resistance
时间窗: Basline and 6 months
Change in insulin resistance from baseline to 6 months
Chang in lipid profile
时间窗: Baseline and 6 months
Change in HDL, LDL, and TG from baseline to 6 months
次要结局
未报告次要终点
研究者
Srinivasan Dasarathy
Assistant Professor
MetroHealth Medical Center
