SCOPYD: Hypovitaminosis D Prediction Score
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vitamin D status 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. |
Biological: Blood sampling
Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
Other: self-administered questionnaire
Patients will fill a self-administered questionnaire the day of inclusion
|
Outcome Measures
Primary Outcome Measures
- 25 (OH) vitamin D blood concentration [The day of inclusion]
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.
Secondary Outcome Measures
- Vitamin D concentration level [The day of inclusion]
The ability of the score to classify adults in one of these three categories: Category 1 : Vitamin D sufficiency (≥30 ng/ml) Category 2 : Hypovitaminosis D between 30 and 10 ng/ml Vitamin D insufficiency (<30 ng/ml) Vitamin D deficiency (<20 ng/ml) Category 3 : Severe deficiency (<10 ng/ml)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Men and women aged 18 to 70 years old
Exclusion Criteria:
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Participation in a study related to vitamin D
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Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
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Pregnancy or breast-feeding
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Renal failure : severe renal impairment, dialysis, having kidney transplant
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Known hepatic impairment
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Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
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Known primary hypo/hyperparathyroidism
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Bone cancer/metastases current or in the last 2 years
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Treatment with antiepileptics
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Long-term treatment with glucocorticoids (> 3 months)
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Treatment with antiretroviral
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Legal incapacity or limited legal capacity
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Non-recipient of French Social Security
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospices Civils de Lyon - Pôle IMER | Lyon Cedex 03 | France | 69424 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD, Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL15_0078