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

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

Completed

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Key information

Conditions

Vitamin D Deficiency Avitaminosis COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Deficiency Diseases Disease Attributes Infections Long COVID Lung Diseases Malnutrition Nidovirales Infections Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luigi di Filippo

Milan, 20132, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: to 01/01/2020 from 31/12/2022

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

Time frame: to 01/01/2020 from 31/12/2022

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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

Abiogen Pharma

Registry information

Official study title

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

Acronym: LONGVITAVAX2

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 11, 2024
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed