Clinical trial
Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital
Name
"REGIDO"
Description
The Endocrinology Unit of the IRCCS San Raffaele Hospital is dedicated to establishing a prospective single-center registry with data from patients undergoing vitamin D supplementation, initiating their first visit to the outpatient unit until December 2029. 1000 patients will be enrolled, aligning with the unit's recent patient influx for hypovitaminosis D.
The registry's goal is to assess the epidemiological trend, identify risk factors, and evaluate the diagnostic and therapeutic clinical management strategies for hypovitaminosis D. It will involve collecting clinical, laboratory, and historical data during outpatient visits, adhering to the standard diagnostic and therapeutic protocols for endocrine-metabolic diseases. This data collection is expected to continue for a duration of ten years.
Trial arms
Trial start
2024-06-01
Estimated PCD
2029-12-01
Trial end
2034-12-01
Status
Not yet recruiting
Treatment
supplementary treatment with vitamin D
observational design
Size
1000
Primary endpoint
Change from baseline of data in outpatient accessing Endocrinology Unit of the IRCCS San Raffaele Hospital for endocrine-metabolic diseases who are on supplementary treatment with vitamin D.
10 years
Eligibility criteria
Inclusion Criteria:
* Adult men and women (age ≥ 18 years) regardless of fertility status and pregnancy/breastfeeding conditions
* Vitamin D supplementation, with any formulation and dosage
* Signing of informed consent
Exclusion Criteria:
* Patients unable to understand and sign informed consent.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2024-07-01
1 organization
1 product
1 indication
Organization
IRCCS San RaffaeleProduct
Vitamin DIndication
Vitamin D Deficiency