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临床试验/EUCTR2006-000945-20-GB
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

发起方
Barts and the London NHS Trust

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