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临床试验/NCT02271971
NCT02271971已完成不适用

Effect of Vitamin D Supplementation on Metabolic Parameters of Patients With Moderate to Severe Psoriasis

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
1
主要终点
Change in Total Cholesterol Levels

研究概览

简要总结

The purpose of this study is to determine whether supplementation with oral vitamin D (cholecalciferol) improves metabolic parameters in patients with moderate to severe psoriasis.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of moderate to severe psoriasis.
  • Being treated with methotrexate with stable doses for al least 1 month.

排除标准

  • Phototherapy within the past 2 months.
  • History of psoriatic arthritis, rheumatoid arthritis, type 1 diabetes mellitus or inflammatory bowel disease.
  • Use of vitamin d supplements or fish oil supplements in the past 2 months.
  • Use of hypolipidemic drugs, hypoglycemic drugs, glucose sensitizers, oral corticosteroids, orlistat, cholestyramine, phenobarbital or phenytoin within the past 2 months.
  • Pregnancy or lactation.

结局指标

主要结局

Change in Total Cholesterol Levels

时间窗: Baseline and 6 weeks

次要结局

  • Change in Fasting Glucose Levels(Baseline and 6 weeks)
  • Change in Low-Density Lipoprotein Levels(Baseline and 6 weeks)
  • Change in High-Density Lipoprotein Levels(Baseline and 6 weeks)
  • Change in Triglycerides Levels(Baseline and 6 weeks)
  • Change in C-Reactive Protein Levels(Baseline and 6 weeks)
  • Change in Vitamin D Levels(Baseline and 6 weeks)
  • Change in PASI (Psoriasis Area Severity Index)(Baseline and 6 weeks)
  • Change in HOMA Index(Baseline and 6 weeks)
  • Change in Glycated Hemoglobin Levels(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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