Clinical trial NCT06452082: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vitamin d Deficiency
COVID-19
Long COVID
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients affected by endocrine-metabolic disease with first visit to the Endocrinology Unit carried out between 01/01/2020 and 12/31/2022

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.

Eligibility 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

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Luigi di Filippo
Study officials:
References: