SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,592
- 试验地点
- 1
- 主要终点
- 25 (OH) vitamin D blood concentration
研究概览
简要总结
Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml).
Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.
We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Men and women aged 18 to 70 years old
排除标准
- •Participation in a study related to vitamin D
- •Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
- •Pregnancy or breast-feeding
- •Renal failure : severe renal impairment, dialysis, having kidney transplant
- •Known hepatic impairment
- •Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
- •Known primary hypo/hyperparathyroidism
- •Bone cancer/metastases current or in the last 2 years
- •Treatment with antiepileptics
- •Long-term treatment with glucocorticoids (> 3 months)
- •Treatment with antiretroviral
- •Legal incapacity or limited legal capacity
- •Non-recipient of French Social Security
研究组 & 干预措施
Vitamin D status
The 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration.
干预措施: Blood sampling (Biological)
Vitamin D status
The 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration.
干预措施: self-administered questionnaire (Other)
结局指标
主要结局
25 (OH) vitamin D blood concentration
时间窗: The day of inclusion
Vitamin D determination will be carried out for each center in a single laboratory by chemiluminescence technique. Vitamin D determination is the gold standard for the development and validation phases of the score. It will define the variables of the self-administered questionnaire to be included in the final score (development phase) and be the gold standard in the evaluation of the performance score (validation phase). The blood sample will be collected after the completion of the questionnaire, on the same day.
次要结局
- Vitamin D concentration level(The day of inclusion)