Hypovitaminosis D Prediction Score (SCOPYD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02822651
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
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)
Primary Purpose: Diagnostic
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

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02822651

Contact: Marie VIPREY, PharmD +33 (0)4 72 11 51 32
Contact: Blandine MERLE, PhD +33 (0)4 72 11 74 80

Hospices Civils de Lyon - Pôle IMER Recruiting
Lyon Cedex 03, France, 69424
Contact: Marie VIPREY, PharmD    +33 (0)4 72 11 51 32   
Contact: Blandine MERLE, PhD    +33 (0)4 72 11 74 80   
Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Anne-Marie SCHOTT-PETHELAZ, MD, PhD Hospices Civils de Lyon - Pôle d'Information Médicale et d'Evaluation de la Recherche

Responsible Party: Hospices Civils de Lyon Identifier: NCT02822651     History of Changes
Other Study ID Numbers: 69HCL15_0078
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents