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Vitamin D has effects on many tissues, and hypovitaminosis D is frequent. In a French survey conducted among 1587 adults, vitamin D insufficiency (<30ng/ml) has been reported in 80% of subjects, including 43% with moderate deficiency (<20ng/ml) and 5% with severe deficiency (<10ng/ml).
Because of the possible consequences of hypovitaminosis D (osteomalacia in adults…), the number of vitamin D determination has increased ten-fold since 2005 in France, reaching 4.5 million € in 2011, and with it the costs for health insurance. However, there is currently no consensus on the strategy for detection, diagnosis and treatment of hypovitaminosis D.
We propose to develop a predictive clinical score of hypovitaminosis D based on the accurate assessment of solar exposure, vitamin D intakes and hypovitaminosis D risk factors collected through a self-administered questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D status | Experimental | The 2500 subjects included in this unique arm will complete a self-administered questionnaire and will have a blood sampling to measure vitamin D blood concentration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Patients will have a blood sampling at inclusion to measure vitamin D blood concentration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25 (OH) vitamin D blood concentration | Vitamin D determination will be carried out for each center in a single laboratory by chemiluminescence technique. Vitamin D determination is the gold standard for the development and validation phases of the score. It will define the variables of the self-administered questionnaire to be included in the final score (development phase) and be the gold standard in the evaluation of the performance score (validation phase). The blood sample will be collected after the completion of the questionnaire, on the same day. | The day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D concentration level | The ability of the score to classify adults in one of these three categories:
| The day of inclusion |
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Inclusion Criteria:
- Men and women aged 18 to 70 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie SCHOTT-PETHELAZ, MD, PhD | Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Pôle IMER | Lyon | 69424 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34444687 | Result | Viprey M, Merle B, Riche B, Freyssenge J, Rippert P, Chakir MA, Thomas T, Malochet-Guinamand S, Cortet B, Breuil V, Chapurlat R, Lafage Proust MH, Carlier MC, Fassier JB, Haesebaert J, Caillet P, Rabilloud M, Schott AM. Development and Validation of a Predictive Model of Hypovitaminosis D in General Adult Population: SCOPYD Study. Nutrients. 2021 Jul 23;13(8):2526. doi: 10.3390/nu13082526. |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| self-administered questionnaire | Other | Patients will fill a self-administered questionnaire the day of inclusion |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |