Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
2015年3月31日 更新者:Lesieur
A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
300
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Lille、法国、59020
- Clinical Nutrition Center Naturalpha (CNCN)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Healthy Volunteers
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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All subjects
300 eligible subjects will perform a blood sampling for a dosage of serum vitamin D and will fill up a study questionnaire during one visit.
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One blood sampling will be performed for a serum vitamin D dosage.
The volume of blood collected will not exceed 4 ml.
The questionnaire includes 19 questions concerning the following topics : a) sun exposure, b) living situation, c) eating habits and Vitamin D dietary intakes.
In addition, two questions will capture demographic data.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Questionnaire internal validity
大体时间:Day 1
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Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
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Day 1
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Questionnaire external validity
大体时间:Day 1
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Prediction of the vitamin D status (threshold value, sensitivity, specificity for vitamin D insufficiency; threshold value, sensitivity, specificity for vitamin D deficiency)
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Day 1
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Confounding factors (demographic data)
大体时间:Day 1
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Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).
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Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
合作者
调查人员
- 研究主任:Sylvie BRETON, R&D Innovation Manager、Lesieur, France
- 首席研究员:Xavier DEPLANQUE, MD、Clinical Nutrition Center Naturalpha, France
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年1月1日
初级完成 (实际的)
2015年2月1日
研究完成 (实际的)
2015年2月1日
研究注册日期
首次提交
2015年2月5日
首先提交符合 QC 标准的
2015年3月31日
首次发布 (估计)
2015年4月3日
研究记录更新
最后更新发布 (估计)
2015年4月3日
上次提交的符合 QC 标准的更新
2015年3月31日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.