跳至主要内容
临床试验/EUCTR2010-019096-29-GB
EUCTR2010-019096-29-GB进行中(未招募)不适用

The effects of oral vitamin D supplementation on cardiovascular disease risk in patients with Myalgic Encephalomyelitis /Chronic Fatigue Syndrome. - Vitamin D supplementation in patients with ME/CFS

niversity of Dundee0 个研究点目标入组 50 人开始时间: 2010年12月21日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients diagnosed with ME/CFS [fulfil the Fukuda (1994) and Canadian (2003)criteria]
  • Serum 25(OH)D levels <75 nmol/l
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Patients not diagnosed by consultant with ME/CFS
  • 2.Patients already taking Vitamin D supplements (fish oils will be permitted)
  • 3.Estimated GFR < 40 mls/min (by MDRD4 method)
  • 4.Adjusted serum calcium <2.15 or > 2.60 mmol/L
  • 5.LFTs > 3x upper limit of normal
  • 6.Known metastatic malignancy
  • 7.History of Kidney stones
  • 8.History of sarcoidosis or Osteoporosis
  • 9.Lying systolic BP < 80 mm Hg
  • 10.Pregnant, lactating or of childbearing age and not taking reliable contraception
  • 11.Patients diagnosed with psychiatric disorder within the past five years
  • 12.Patients diagnosed with schizophrenia, mania, substance abuse/dependence, or an eating disorder at any time
  • 13.Patients with other known organic cause for their symptoms
  • 14.Unable to give written informed consent

研究者

发起方
niversity of Dundee

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