EUCTR2015-003910-26-PT进行中（未招募）1 期
Fase II, unicenter, open, randomized trial to evaluate the response of Th17 and T regulatory lymphocytes to 24 weeks supplementation with cholecalciferol in patients with arterial hypertension, obesity and vitamin D deficiency.
úcleo de Estudos de Hipertensão da Beira Interior0 个研究点目标入组 30 人开始时间: 2017年7月10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
- 30
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
- •- Obtention of free and informed consent to participate, dated and signed by the participant
- •- Free willing and availability to participate in the all course of the trial as well as to accomplish with all the procedures of the trial protocol
- •- Hability to take autonomously oral medication and capacity to adhere to the therapeutic scheme proposed by the trial
- •- In women of child-bearing potential use of efficacious contraception
- •- Age between 45-65 years
- •- Treated essential hypertension (systolic blood pressure ¿ 159 mmHg and diastolic blood pressure ¿ 99 mmHg)
- •- Obesity (body mass index ¿ 30 Kg/m2) or metabolic syndrome by the International Diabetes Federation criteria
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Actual or previous medication with modulatores of the immune system (e.g. steroids, immunossupressive medication)
- •- Actual treatment with antihistamines
- •- Autoimmmune disease
- •- Sarcoidosis
- •- Active infectious or neoplasic disease
- •- Other chronic infectious or inflammatory diseases (e.g. tuberculosis, diabetic foot, chronic viral hepatitis)
- •- Glomerular filtration rate < 60 mL/min/1,73m2
- •- Vitamin D in plasma VD ¿ 30 ng/mL
- •- Serum calcium > 10.5 mg/dL
- •- Kidney stones or nephrocalcinosis
- •- Active smoker
- •- Active treatment with cholecalciferol before the beggining of the trial
- •- Pregnacy, breastfeeding or non-utilization of efficacious contraceptive method
- •- Intolerance to cholecalciferol
- •- Simultaneous participation in another trial
研究者
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