Hypovitaminosis D Prediction Score (SCOPYD)
Primary Purpose
Vitamin D Status
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
self-administered questionnaire
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin D Status
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon - Pôle IMER
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D status
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Vitamin D concentration level
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)
Full Information
NCT ID
NCT02822651
First Posted
June 30, 2016
Last Updated
December 20, 2018
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02822651
Brief Title
Hypovitaminosis D Prediction Score
Acronym
SCOPYD
Official Title
SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Status
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2592 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D status
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
Intervention Type
Other
Intervention Name(s)
self-administered questionnaire
Intervention Description
Patients will fill a self-administered questionnaire the day of inclusion
Primary Outcome Measure Information:
Title
25 (OH) vitamin D blood concentration
Description
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.
Time Frame
The day of inclusion
Secondary Outcome Measure Information:
Title
Vitamin D concentration level
Description
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)
Time Frame
The day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie SCHOTT-PETHELAZ, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Pôle IMER
City
Lyon Cedex 03
ZIP/Postal Code
69424
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypovitaminosis D Prediction Score
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