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临床试验/ACTRN12610000392066
ACTRN12610000392066招募中3 期

The effects of a high-dose oral vitamin D loading dose compared with placebo with maintenance oral vitamin D and calcium on correction of hypovitaminosis D, lower extremity function (gait velocity), falls and fractures among older people after hip fracture surgery

orthern Sydney Central Coast Area Health Service, Gosford Hospital0 个研究点目标入组 450 人开始时间: 2010年5月14日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
450

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
Blinded (masking used)

入排标准

年龄范围
65 Years 至 o limit(—)
性别
All

入选标准

  • 1. Adults (aged 65 or over) presenting with a hip fracture requiring surgical treatment 2. Able to provide informed consent, either directly or via the person responsible” 3. Willingness to participate in and comply with the study 4. Deemed suitable by treating medical team for consent 5. Able to take loading dose by 7 days after operation

排除标准

  • 1. Unable to read, speak or write English language (and interpreter not available) 2. Bed-bound prior to fracture, or life expectancy deemed less than 1 month (by the treating clinical staff) 3. Hypercalcaemia (serum calcium, >2.65mmol/L). 4. History of renal stones 5. Thyrotoxicosis 6. Paget’s disease 7. Malignancy (except skin cancer) and associated pathological fractures 8. Significant renal impairment (serum creatinine, >0.15mmol/L) 9. Liver disease (alanine aminotransferase or aspartate aminotransferase level >2 times the upper limit of the normal range); 10. Existing treatment with calcitriol or vitamin D2 > than 1000IU daily.

研究者

发起方
orthern Sydney Central Coast Area Health Service, Gosford Hospital

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