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临床试验/NCT04038853
NCT04038853已完成4 期

Use of Vitamin D in Treatment of Non-Alcoholic Fatty Liver Disease Detected by Transient Elastography

University Hospital Rijeka0 个研究点目标入组 360 人开始时间: 2015年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
360
主要终点
Elastographic parameter of steatosis

研究概览

简要总结

This study evaluates the influence of vitamin D in reducing laboratory, elastographic (Fibroscan) and metabolic components of NAFLD. Half of the patients will receive vitamin D (Plivit D3) while the other half will receive placebo

详细描述

In this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, or family physicians in the Department of Gastroenterology CHC Rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).Nonalcoholic fatty liver disease will be defined by transient elastography (FibroScan, Echosens, Paris); Controlled Attenuation Parameter (CAP) for assesment of liver steatosis and Liver Stiffness Measurements (LSM) for liver fibrosis. In all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease.

This study will include 450 patients. Taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. Patients will be randomized into two groups. The first group will be consisted of the patients with NAFLD who will be receiving original medication during the 12 month period. The second group will be consisted of the patients with NAFLD who will be receiving placebo during the 12 months period, which will be identical to the original medication in its packaging and form.

After the 6 and 12 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of NAFLD (insulin resistance, lipidogram and serum glucose), as well as the TE-CAP in order to evaluate the efficiency of Plivit D3 for the treatment of NAFLD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
  • signed informed consent
  • possibility to follow instruction and the protocol

排除标准

  • chronic B or C hepatitis
  • usage of hepatotoxic drugs in the period of 6 months before inclusion
  • chronic kidney insufficiency (grade 4 and 5), hemodialysis
  • any other chronic liver disease
  • opioid dependancy
  • any malignancy
  • HIV seropositivity
  • alcohol abuse
  • pregnancy
  • inability to follow the protocol

研究组 & 干预措施

Vitamin D

Experimental

Intervention drug, containing 1,25-dihydroxy-vitamin D, comes in original packages as vials containing a total amount of 10 ml of clear solution. 5 drops accounting for 1000 IU of 1,25-dihydroxy-vitamin D will be administered orally on a daily basis.

干预措施: 1,25-Dihydroxyvitamin D (Drug)

Placebo

Placebo Comparator

A placebo identical to the study intervention drug in all its characteristics (package, visual characteristics of the fluid, smell, and taste) will be administered in the same manner.

干预措施: Placebo (Drug)

结局指标

主要结局

Elastographic parameter of steatosis

时间窗: Week 0 - initiation; after 6 months; and after 12 months (end of study)

Change of elastographic parameter of steatosis (Controlled Attenuation Parameter; CAP) during the 6 and 12 months period

Elastographic parameter of fibrosis

时间窗: Week 0 - initiation; after 6 months; and after 12 months (end of study)

Change of elastographic parameter of fibrosis (liver stiffness measurements; LSM) during the 6 and 12 months period

次要结局

  • Aspartate transaminase(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Alanine transaminase(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Insuline Resistance(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Low-density lipoprotein(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • High-density lipoprotein(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Gamma-glutamyl transferase(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Total cholesterol(Week 0 - initiation; after 6 months; and after 12 months (end of study))
  • Triglyceride(Week 0 - initiation; after 6 months; and after 12 months (end of study))

研究者

发起方
University Hospital Rijeka
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ivana Mikolasevic

Asst. Prof.

University Hospital Rijeka

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