ISRCTN59927814已完成不适用
Vitamin D supplementation in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients: a randomised, placebo-controlled, parallel, double-blind study
niversity of Dundee0 个研究点目标入组 50 人开始时间: 2010年3月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Patients diagnosed with ME/CFS (fulfils the Fukuda [1994] and Canadian [2003] criteria)
- •2. Serum 25(OH)D levels < 75 nmol/l
- •3. Male or female, aged 18 - 65
排除标准
- •1. Patients not diagnosed with ME/CFS
- •2. Patients already taking Vitamin D supplements (fish oils will be permitted)
- •3. Estimated Glomerular Filtration Rate (GFR) < 40 ml/min (by MDRD4 method)
- •4. Adjusted serum calcium < 2.15 or > 2.60 mmol/L
- •5. Liver Function Test (LFT) > 3x upper limit of normal (ULN)
- •6. Known metastatic malignancy
- •7. History of kidney stones
- •8. History of sarcoidosis or osteoporosis
- •9. Lying systolic blood pressure (BP) < 80 mm Hg
- •10. Pregnant, lactating or of childbearing age and not taking reliable contraception
- •11. Patients diagnosed with psychiatric disorder (including depression) within the past 5 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
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