Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
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
- 是
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
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
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
Metzger Muriel
MD
Clalit Health Services
