A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Lesieur
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Questionnaire internal validity
研究概览
简要总结
The purpose of this clinical study is to evaluate the metrological properties of a questionnaire that aims to identify the vitamin D status in reference to a vitamin D blood dosage.
详细描述
Each subject will perform only one visit (visit V1). The study duration per subject will last about 2 hours. During this visit V1, the subjects will perform a medical exam in order to check their eligibility (general statement and check of inclusion / non-inclusion criteria). The eligible subjects will fill up a study questionnaire and will perform a blood sampling for a dosage of serum vitamin D.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers
- •Subject able to communicate with the investigator and the study team, able to read and write and follow all study instructions.
- •Written informed consent provided and signed prior screening, after receiving and understanding the subject information.
- •Registered with the French Social Security, in agreement with the French law on biomedical experimentation.
排除标准
- •Subject with diagnosed osteoporosis, osteopenia or osteomalacia.
- •Subject with known disease that contributes in osteoporosis: Rheumatoid arthritis, Malabsorption syndrome, Inflammatory bowel disease, Hyperthyroidism, Hyperparathyroidism.
- •Subject with known hepatic impairment.
- •Subject with known liver impairment or with a history of renal transplantation.
- •Subject with history of cancer.
- •Subject with history of bariatric surgery.
- •Subject taking or having taken osteoporosis inducing treatment, or treatment with an effect on calcium and phosphorus metabolism during the 3 months prior the visit: Corticosteroids, Enzyme inducing anticonvulsants, Heparin.
- •Subject requiring vitamin D supplementation for a diagnosed pathology.
- •Pregnant or breastfeeding Female.
- •Subject with history of alcohol or drug abuse.
- •Participation to any other clinical trial simultaneously and/or not having ended the exclusion period of another clinical trial.
- •Subject of legal age unable of giving consent.
- •Subject deprived of liberty by judicial or administrative decision.
- •Subject of legal age under legal protection.
- •Subject having received over 4500 Euros for clinical trial participation within the prior year including the indemnity for the present study.
结局指标
主要结局
Questionnaire internal validity
时间窗: Day 1
Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
Questionnaire external validity
时间窗: Day 1
Prediction of the vitamin D status (threshold value, sensitivity, specificity for vitamin D insufficiency; threshold value, sensitivity, specificity for vitamin D deficiency)
Confounding factors (demographic data)
时间窗: Day 1
Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).
次要结局
未报告次要终点