CompletedNot Applicable

Risk in Devel Long-COVID in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Suppl

Italy200 participantsStarted 2024-03-20

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (For aim I): * 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 Exclusion Criteria (For aim I): * 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 Inclusion Criteria (For aim 2) \-- 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 (For aim 2): * 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 vac…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol.

Timeframe: to 01/01/2020 from 31/12/2022

Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.

Timeframe: to 01/01/2020 from 31/12/2022

Trial details

NCT IDNCT06452082

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-24

View on ClinicalTrials.gov More Vitamin d Deficiency trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol.

Timeframe: to 01/01/2020 from 31/12/2022

Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.

Timeframe: to 01/01/2020 from 31/12/2022