EUCTR2006-000945-20-GB进行中(未招募)1 期
To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis
Barts and the London NHS Trust0 个研究点目标入组 40 人开始时间: 2006年9月18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
- 40
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
入选标准
- •Patients with a diagnosis of CF (positive sweat test and genotype testing)
- •Patients aged over 16 years (post pubertal-stage IV Tanner)
- •Patients who are pancreatic insufficient (i.e. with a positive faecal elastase test and requiring pancreatic enzyme supplementation)
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients already taking vitamin K supplementation,
- •Patients with abnormally low vitamin D levels (<30 µg)
- •Patients on maintenance oral corticosteroids
- •Patients with osteopaenia or osteoporosis and taking bisphosphonates
- •Patients who are considered to have very sedentary lifestyle or follow a rigorous exercise training programme
- •Patients with overt liver disease
- •Patients who do not consent to participate
- •Patients with a life expectancy of less than 12 months
- •Patients who are non-compliant with maintenance therapies
研究者
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