EUCTR2011-002585-20-DK进行中（未招募）1 期
The role of vitamin D supplementation on well-being and symptoms of depression during the Winter season in health service staff.
Psykiatrien i Region Syddanmark0 个研究点目标入组 172 人开始时间: 2011年8月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 172
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
- •Employed at either Sydvestjysk Sygehus or Psykiatrien i Region Syddanmark, Esbjerg, Denmark.
- •Seasonal Pattern Assessment Questionnaire (SPAQ-SAD) score above 11.
- •Negative urine hCG test in women of childbearing potential.
- •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 172
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Fulfilled ICD-10 criteria for diseases F20-29 and F31.
- •Sarcoidosis.
- •Tuberculosis.
- •Decreased kidney function measured as estimated GFR (4-variable MDRD equation) < 60 ml per minute.
- •Increased plasma ionized calcium concentration above 1,40 mmoles per liter.
- •Increased plasma phosphate concentration above 1,50 mmoles per liter for women, above 1,60 mmoles per liter for men below 50 years of age and above 1,35 mmoles per liter for men equal to and above 50 years of age.
- •Plasma concentration of 25-hydroxy-vitamin D3 below 10 nmoles per liter or above 160 nmoles per liter.
- •Hyperparathyroidism measured as PTH concentration above 9,2 pmoles per liter.
- •Pregnancy or wanted pregnancy.
- •Nursing women.
- •Already participated in the trial.
- •Daily intake of vitamin D3 above 10 micrograms.
- •Allergy towards tablet contents.
- •No informed consent.
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