Vitamin d DeficiencyLONGVITAVAX2NCT06452082
Risk in Devel Long-COVID in Contracting SARS-CoV-2 Infection After COVID-19 Vaccination in Relation to Vitamin D3 Suppl
An observational study of Vitamin d Deficiency and COVID-19, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin d Deficiency, COVID-19, Long COVID
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2024to 10 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
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- -- 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
Who cannot join
- 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
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- patients unable to sign the informed consent
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the detailed description
Anamnestic, laboratory and therapeutic data will be collected during outpatient visits.
- Conditions
- Vitamin d Deficiency, COVID-19, Long COVID
- Medical subject headings
- Vitamin D Deficiency, COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients on therapy with cholecalciferol | Not described | |
| patients not on cholecalciferol therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: to 01/01/2020 from 31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start20 Mar 2024
- Primary completion24 Jul 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin d DeficiencyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Abiogen Pharma
- Responsible party
- Principal investigator, Luigi Di Filippo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452082
- Sponsor's protocol ID
- ABIO/NC/06
- Acronym
- LONGVITAVAX2
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06452082
- Acronym / sponsor ID
- LONGVITAVAX2 / ABIO/NC/06
- Conditions
- Vitamin d Deficiency, COVID-19, Long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Abiogen Pharma
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients on therapy with cholecalciferol | – | – |
| patients not on cholecalciferol therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin d Deficiency and COVID-19, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.