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临床试验/NCT03084328
NCT03084328已完成不适用

Vitamin D Replacement in Nonalcoholic Fatty Liver Disease

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年1月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Srinivasan Dasarathy

Assistant Professor

MetroHealth Medical Center

研究点 (1)

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