Hypovitaminosis D Prediction Score (SCOPYD)
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|ClinicalTrials.gov Identifier: NCT02822651|
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : August 9, 2017
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|
|Vitamin D Status||Biological: Blood sampling Other: self-administered questionnaire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D|
|Actual Study Start Date :||September 19, 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
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
- 25 (OH) vitamin D blood concentration [ Time Frame: 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.
- Vitamin D concentration level [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822651
|Contact: Marie VIPREY, PharmD||+33 (0)4 72 11 51 email@example.com|
|Contact: Blandine MERLE, PhD||+33 (0)4 72 11 74 firstname.lastname@example.org|
|Hospices Civils de Lyon - Pôle IMER||Recruiting|
|Lyon Cedex 03, France, 69424|
|Contact: Marie VIPREY, PharmD +33 (0)4 72 11 51 32 email@example.com|
|Contact: Blandine MERLE, PhD +33 (0)4 72 11 74 80 firstname.lastname@example.org|
|Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD|
|Principal Investigator:||Anne-Marie SCHOTT-PETHELAZ, MD, PhD||Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche|