Risk in Devel Long-COVID in Contracting SARS-CoV-2 Infect... | NCT06452082

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

NCT06452082

Sponsor

IRCCS San Raffaele

Status

Completed

Last Update Posted

Apr 8, 2026Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Vitamin d Deficiency
COVID-19
Long COVID

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Actual

Primary Completion Date

Jul 24, 2025Actual

Completion Date

Sep 10, 2025Actual

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 6, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
Abiogen Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
patients on therapy with cholecalciferol
patients not on cholecalciferol therapy

ID	Term
D014808	Vitamin D Deficiency
D000086382	COVID-19
D000094024	Post-Acute COVID-19 Syndrome

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders