Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
- Conditions
- Healthy Volunteers
- Interventions
- Procedure: Blood samplingOther: Predictive questionnaire for vitamin D insufficiency
- Registration Number
- NCT02408679
- Lead Sponsor
- Lesieur
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All subjects Blood sampling 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. All subjects Predictive questionnaire for vitamin D insufficiency 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.
- Primary Outcome Measures
Name Time Method Questionnaire internal validity Day 1 Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
Questionnaire external validity 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) Day 1 Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Nutrition Center Naturalpha (CNCN)
🇫🇷Lille, France