A Study to Validate a Predictive Questionnaire for Vitamin D Insufficiency in Healthy Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Lesieur
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Questionnaire internal validity
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Questionnaire internal validity
Time Frame: Day 1
Evaluation of the internal coherence and factorial structure of the questionnaire, establishment of scoring rules
Questionnaire external validity
Time Frame: 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)
Time Frame: Day 1
Interests for coupling the study questionnaire and demographic data (age, gender, Body Mass Index, phototype).