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

NCT06452082 | Completed

• 1 other identifier: ABIO/NC/06
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Vitamin d Deficiency; COVID-19; Long COVID

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

patients on therapy with cholecalciferol

patients not on cholecalciferol therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• \-- 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
• age ≤ 18
• pregnant or breastfeeding women

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Abiogen Pharma: collaborator

Study Sites (1)

Luigi di Filippo

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Vitamin D Deficiency; COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 11, 2024
• Study Start: March 20, 2024
• Primary Completion: July 24, 2025
• Study Completion: September 10, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)