Retrospective Observational Study on the Risk in Developing Long-COVID Syndrome and in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Supplementation

NCT ID: NCT06452082

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-20

Study Completion Date

2027-03-31

Brief Summary

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The aim of this observational retrospective study is to evaluate the effect of supplementation with cholecalciferol D3 in reducing the risk of:

* occurence of Long COVID syndrome after acute COVID-19 illness
* occurence of SARS-CoV-2 infection after anti-COVID-19 vaccination

Detailed Description

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Anamnestic, laboratory and therapeutic data will be collected during outpatient visits.

Conditions

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Vitamin d Deficiency COVID-19 Long COVID

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients on therapy with cholecalciferol

No interventions assigned to this group

patients not on cholecalciferol therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age ≥18
* outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022
* previous SARS CoV-2 infection
* clinical,anamnestic and therapeutic data 6 months post SARS CoV-2 infection
* data on cholecalciferol supplementation
* signature of informed consent


\-- age ≥18

* outpatient with first visit on Endocrinology Department performed from 01/01/2020 to 31/12/2022
* vaccination with BNT162b2 Biontec mRNA Pfizer/BioNtech
* clinical, anamnestic and therapeutic data 6 months post SARS CoV-2 infection
* data on cholecalciferol supplementation
* signature of informed consent

Exclusion Criteria

* age ≤ 18
* pregnant or breastfeeding women
* patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions
* patients treated with drugs that interfere with vitamin D metabolism
* first vaccination anti Sars COVID performed before the acute infection
* first vaccination performed within 6 months of the acute infection
* patients unable to sign the informed consent


* age ≤ 18
* pregnant or breastfeeding women
* patients suffering from primary and/or acquired immunodeficiency and/or severe impairment of general clinical conditions
* patients treated with drugs that interfere with vitamin D metabolism
* additional vaccination performed before 6-12 months
* acute infection before the vaccination
* patients unable to sign the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Luigi Di Filippo

Medical Physician Specialist in Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Luigi di Filippo

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ABIO/NC/06

Identifier Type: -

Identifier Source: org_study_id

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