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

Retrospective Observational Study on the Risk 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 Suppl in Outpatients of Endocr Dept

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06452082
Acronym
LONGVITAVAX2
Enrollment
200
Registered
2024-06-11
Start date
2024-03-20
Completion date
2025-09-10
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Long COVID, Vitamin d Deficiency

Brief 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

Detailed description

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

Interventions

None listed

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER
Abiogen Pharma
CollaboratorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analyse the rates of Long COVID syndrome occurance after acute COVID-19 disease in patients treated with and without cholecalciferol.to 01/01/2020 from 31/12/2022Analyse 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
Analyse the rates of SARS-CoV-2 infection occurrence after anti-COVID-19 vaccination in patients treated with and without cholecalciferol.to 01/01/2020 from 31/12/2022Analyse 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026