Healthy Volunteers
Conditions
Keywords
Vitamin D, Vitamin D Deficiency, Vitamin D Insufficiency, Healthy adults, Predictive questionnaire
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.
Interventions
PROCEDUREBlood sampling
One blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml.
OTHERPredictive questionnaire for vitamin D insufficiency
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.
Sponsors
Naturalpha
Lesieur
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed