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临床试验/NCT03582917
NCT03582917招募中2 期

The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis

University of Ioannina2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
80
试验地点
2
主要终点
25(OH)D

研究概览

简要总结

The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.

详细描述

The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m ^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).

Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Adolescent Scoliosis
  • Risser sign <3-4

排除标准

  • Neuromuscular diseases
  • metabolic disease
  • Liver, lung, thyroid and parathyroid gland disorders.

研究组 & 干预措施

Alphacalscidol

Experimental

0,5mg tablet by mouth, one each day for one year

干预措施: Alphacalcidol (Drug)

结局指标

主要结局

25(OH)D

时间窗: 48 weeks

Measurement of the major metabolite of vitamin D

X - rays

时间窗: 48 weeks

Cobb angle measurement

Dexa

时间窗: 48 weeks

BMD and Z - score measurement

BMD (weight in kilograms, height in meters)

时间窗: 48 weeks

weight and height will be combined to report BMI in kg/m\^2

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

University of Ioannina

研究点 (2)

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