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

April 2, 2026 updated by: Luigi Di Filippo, IRCCS San Raffaele

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

outpatient clinics who will access of the Endocrinology Unit of the IRCCS San Raffaele Hospital for endocrine-metabolic diseases and who are on supplementary treatment with vitamin D until December 2029

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Luigi di Filippo, MD, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • "REGIDO"

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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