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 (LONGVITAVAX2)

San Donato Group (GSD)

Status: Active, not recruiting

Conditions: COVID-19; Vitamin d Deficiency; Long COVID

Study type: Observational

Funder types: Other

Identifiers

NCT06452082

ABIO/NC/06

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 2 patient groups

patients on therapy with cholecalciferol

patients not on cholecalciferol therapy