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临床试验/NCT01025128
NCT01025128已完成4 期

Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density

Clalit Health Services1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
210
试验地点
1
主要终点
plasma vitamin D level

研究概览

简要总结

Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements. However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of the city population, is at risk of developing vitamin D deficiency due to low sun exposure, as consequence of its dressing code covering most of the body and very limited time of outside activities. The investigators aim is to check whether vitamin D deficiency is found more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox male population, and to study its eventual consequences. Correlation between vitamin D levels and PTH levels will be examined, according to age and to creatinine levels. Bone mineral density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the main cause of low BMD in these subjects.

详细描述

Subjects:

The study will include 200 males aged 18-70, living in the Jerusalem area. Enrollment will be distributed among 8 clinics of the Clalit Health Services: 4 clinics located in predominantly ultra-Orthodox areas (group A) and 4 clinics located in mixed areas (Group B).

Each group of clinics will enroll 100 subjects as sub-defined:

Age 18-24: 30 patients (Groups A1 and B1) Age 25-39: 30 patients (Groups A2 and B2) Age 40-54: 20 patients (Groups A3 and B3) Age 55-70: 20 patients (Groups A4 and B4)

Study protocol:

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male subjects aged 18-70
  • If age below 40 must not be under any chronic medication

排除标准

  • Medication: anti-convulsivants, non-topical steroids (past or present), anti-rejection medications
  • Malabsorptive diseases (Crohn's disease, cystic fibrosis,Whipple' disease, s/p bariatric surgery)
  • Morbid obesity (BMI above 35)
  • Rheumatoid arthritis
  • Liver failure
  • Nephrotic syndrome
  • Chronic kidney disease
  • Genetic disorder
  • Malignancy
  • Primary hyperparathyroidism
  • Granulomatous disease
  • Hyperthyroidism
  • Nephrolithiasis (present or past)
  • S/P skin grafts surgery
  • Mental disorder or cognitive disorder

研究组 & 干预措施

group A low D

Active Comparator

ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels

干预措施: 25 OH vitamin D (Drug)

group B low D

Active Comparator

mixed population clinics patients aged 18-39 with lowest vitamin D levels

干预措施: 25 OH vitamin D (Drug)

结局指标

主要结局

plasma vitamin D level

时间窗: 6 months

次要结局

  • bone mineral density after vitamin D supplementation in vitamin D deficient subjects(13 months)
  • plasma PTH level(6 months)
  • bone mineral density before vitamin D supplementation(8 months)

研究者

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

Metzger Muriel

MD

Clalit Health Services

研究点 (1)

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