Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital

Not yet recruiting

• Conditions: Hypovitaminosis D

• Registration Number: NCT06481111
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2029-12
• Study Completion: 2034-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	The main outcome of the study is to assess the prevalence changes of major comorbidities and their complications including cardiovascular diseases, diabetes, cancer, and osteoporosis, during the study-period in relation to the use and characteristics of vitamin D supplementation, in order to evaluate the potential influence of vitamin D use on patient's outcomes. The pathological conditions will be diagnosed according to current major guidelines and clinical practice.