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临床试验/NCT03605173
NCT03605173Unknown不适用

Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?

Limin Rong1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
125
试验地点
1
主要终点
Free vitamin D

研究概览

简要总结

According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.

详细描述

Osteoporosis is a major health issue worldwide as it increases the risk of fragility fracture and chronic disability. The studies on the association between vitamin d and osteoporosis have yielded conflicting results. While some have shown a positive correlation, others have concluded that there is no association at all. Recent reports have shown vitamin D supplementation do not prevent fragile fractures. This might be because the actual vitamin D status, which should be the free vitamin D, has not been measured.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
48 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with a diagnosis of osteoporosis and with or without fracture
  • post- menopausal women
  • age > 48 years

排除标准

  • vitamin D supplementation in recent 6 months
  • patients on steroid
  • age < 48 years
  • patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism

研究组 & 干预措施

free vitamin d

Experimental

free vitamin is directly measured from blood serum using an ELISA kit

干预措施: free vitamin d test (Diagnostic Test)

total vitamin d

Experimental

Total vitamin d is measured routinely from blood serum

干预措施: total vitamin d (Diagnostic Test)

结局指标

主要结局

Free vitamin D

时间窗: ! day

measured using free vitamin D Elisa kit

Total vitamin D

时间窗: ! day

It is measured as a part of routine investigation at the time of admission

次要结局

  • BMD(! day)
  • Vertebral fracture(! day)

研究者

发起方
Limin Rong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Limin Rong

professor, department of spine surgery

Third Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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