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

NCT06481111 | Recruiting

• 1 other identifier: "REGIDO"
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Interventions

supplementary treatment with vitamin D DRUG

observational design

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients unable to understand and sign informed consent.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luigi di Filippo, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Di Filippo, MD

CONTACT

+39022643; difilippo.luigi@hsr.it

Endocrinology Trial Office, CRN

CONTACT

022643; trials.endocrinologia@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Physician Specialist in Endocrinology

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 1, 2024
• Study Start: July 10, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 1, 2034
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)