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NCT Number: NCT06481111

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

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.

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Key information

Conditions

Hypovitaminosis D Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supplementary treatment with vitamin D

Drug

observational design

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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Endocrinology Trial Office, CRN

CONTACT

[email protected]

022643 ext. 5062

Luigi Di Filippo, MD

CONTACT

[email protected]

+39022643 ext. 5110

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Jul 1, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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