ACTRN12609001069246终止4 期
oading Dose Vitamin D Study: Cholecalciferol 5000units daily compared to 1000units daily for the treatment of moderate to severe vitamin D deficiency in Elderly Patients (LDVD Study)
Alfred Hosptial0 个研究点目标入组 60 人开始时间: 2009年12月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 o limit(—)
- 性别
- All
入选标准
- •All elderly patients above the age of 65 years old admitted to The Alfred, Caulfield, Sandringham Hospital during study period with moderate to severe vitamin D deficiency (<25nmol/L) with risk factors for osteoporosis as per National Prescribing Service (NPS) guidelines.
排除标准
- •Patients with severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) less than 10mL/min estimated by Cockcroft Gault formula will be excluded due to their inability to convert cholecalciferol into the activated vitamin D form for use in the body. These patients need to be treated with 1,25 dihydroxyvitamin D.
- •Patients who have been stabilised on continuous cholecalciferol treatment for more than 6 weeks will be excluded from the trial. Patients who have been on cholecalciferol 1000units or less for a period of less than six weeks treatment would still be considered for enrolment. This is based on the assumption that these patients will not reach steady state due to the long half life of cholecalciferol (~3 weeks).
- •Patients with swallowing difficulties, currently there are only oral formulations available in Australia therefore it would be not feasible to enrol these patients into the trial.
研究者
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