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NCT06452082 Clinical Trial

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

COVID-19 Clinical Trial

— LONGVITAVAX2  

Official title:
Retrospective Observational Study on the Risk in Developing Long-COVID Syndrome After Acute COVID-19 Disease and in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Supplementation in Outpatients of Endocrinology Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06452082
Other study ID # ABIO/NC/06
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date March 2027

Study information
Verified date June 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date March 2027
Est. primary completion date March 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 vaccination - patients unable to sign the informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Luigi di Filippo Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol. Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in outpatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022 to 01/01/2020 from 31/12/2022
Primary Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol. Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in oupatients treated with and without cholecalciferol between 01/01/2020 and 31/12/2022 to 01/01/2020 from 31/12/2022
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