Hypovitaminosis D Prediction Score

Vitamin D Status Clinical Trial

— SCOPYD  

Official title:

SCOPYD Study: Development of a Predictive Clinical Score of Hypovitaminosis D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822651
• Other study ID #: 69HCL15_0078
• Status: Completed
• Phase: N/A
• Start date: September 19, 2016
• Est. completion date: November 17, 2017

Study information

• Verified date: December 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2592
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Rickets
• Vitamin D Deficiency
• Vitamin D Status

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Pôle IMER	Lyon Cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The day of inclusion
Secondary	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)	The day of inclusion