EUCTR2010-023531-42-DK进行中(未招募)1 期
The role of vitamin D supplementation on symptoms in patients treated for depression. A double-blind randomized trial.
Psykiatrien i Region Syddanmark0 个研究点目标入组 400 人开始时间: 2011年2月9日最近更新:
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
- 400
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
- •Depression as defined by fulfilled ICD-10 criteria for diseases F32.1-3, F33.1-3.
- •Age between 18 and 75 years (both included).
- •Admission not required at the time of inclusion.
- •Secure contraception 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Fulfilled ICD-10 criteria for diseases F20-29, F30-31 or change of principal diagnosis during the study.
- •Sarcoidosis.
- •Tuberculosis.
- •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 5 nmoles per liter or above 100 nmoles per liter.
- •Pregnancy or wanted pregnancy.
- •Nursing women.
- •Already participated in the trial.
- •Daily intake of vitamin D3 above 10 mikrograms.
- •Allergy towards tablet contents.
- •Not received electroconvulsive treatment within the last 6 months.
- •No informed consent.
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