- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822651
Hypovitaminosis D Prediction Score (SCOPYD)
SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lyon Cedex 03, France, 69424
- Hospices Civils de Lyon - Pôle IMER
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged 18 to 70 years old
Exclusion Criteria:
- Participation in a study related to vitamin D
- Taking at least 80 000 IU vitamin D in the last 3 months as a single dose
- Pregnancy or breast-feeding
- Renal failure : severe renal impairment, dialysis, having kidney transplant
- Known hepatic impairment
- Gastrointestinal disorders: Celiac disease, Crohn's disease, ulcerative colitis, bariatric surgery, gastrointestinal surgery with stoma
- Known primary hypo/hyperparathyroidism
- Bone cancer/metastases current or in the last 2 years
- Treatment with antiepileptics
- Long-term treatment with glucocorticoids (> 3 months)
- Treatment with antiretroviral
- Legal incapacity or limited legal capacity
- Non-recipient of French Social Security
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
Patients will fill a self-administered questionnaire the day of inclusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
The day of inclusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D concentration level
Time Frame: The day of inclusion
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The ability of the score to classify adults in one of these three categories:
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The day of inclusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD, Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL15_0078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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