Prospective Monocentric Registry of Patients Undergoing Vitamin D Treatment at San Raffaele Hospital
ConditionHypovitaminosis D
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients unable to understand and sign informed consent.
Trial 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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
supplementary treatment with vitamin D
Drugobservational design
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov