Healthy VolunteersNCT05673980
Oral Vitamin D2 for Prevention of COVID-19
A study testing Vitamin D2 in people with Healthy Volunteers, run by Peking University Third Hospital at 1 site in China.
Trial summary
A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2022to 20 Feb 2023
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the clinical study and sign the informed consent;
- Staff members of Peking University Third Hospital, including the hospital headquarters, Capital International Airport Hospital, North Hospital, Beijing Haidian Hospital, Peking University Third Hospital Yanqing Hospital and Peking University Third Hospital Chongli Hospital;
- Test negative for COVID-19 antigen and have no symptoms related to COVID-19.
Who cannot join
- Hospital staff with serious underlying diseases;
- Pregnant and lactating women;
- Long-term vegetarians;
- Long-term chronic diarrhea, history of subtotal gastrectomy, biliary obstructive disease and pancreatic disease.
Trial locations and contacts
1 site in 1 country.
Chunli Song, Pro. contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Huan Wang, Ms., 18251825313 ext. +86, wh18324178960@163.com
Chunli Song, Pro.
About this study
Official title: A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19
A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks.
Read the detailed description
This study is a randomized controlled multicenter clinical trial. Participants who meet the inclusion criteria can be included in this trial after signing informed consent. A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks. Throughout the trial, participants' nucleic acid or antigen results, 25(OH)D concentrations, etc., need to be tested.
- Conditions
- Healthy Volunteers
- Being tested
- Vitamin D2, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Drug
Also called cholecalciferol
Participants in the vitamin D2 group received 200,000 IU of vitamin D2 orally on the first day of the trial and again two weeks later
placeboOther
This group will not do any intervention
| Study group | Role | What they receive |
|---|---|---|
| vitamin D2 | Experimental | Oral dose of Vitamin D2 every two weeks Receives: Drug: Vitamin D2 |
| Placebo | Placebo comparator | Without any intervention Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection
The test will be nucleic acid or antigen testing twice a week for four weeks
Measured: 4 weeks
Secondary outcomes (4)
The duration of a positive to negative antigen test after infection with COVID-19
Antigen test results were recorded twice a week for four weeks
Measured: up to 4 weeks
The duration of symptoms in COVID-19 positive participants
For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.
Measured: up to 4 weeks
The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days
For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.
Measured: 4 weeks
The proportion of asymptomatic COVID-19 infected persons (those who test positive for the etiology of COVID-19 but have no related clinical manifestations)
For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start18 Dec 2022
- Primary completion19 Jan 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Responsible party
- Sponsor
- Investigators
- Chunli Song, Pro., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673980
- Sponsor's protocol ID
- M2022828
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Liu H, Huang J, Meng X, Wang W, Xiao W, Liu D, Tao L, Song C. Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial. Clin Interv Aging. 2025 Nov 27;20:2219-2230. doi: 10.2147/CIA.S541940. eCollection 2025.
PubMed 41341143Wang H, Tao L, Cui L, Chen Y, Liu D, Xue L, Yang Y, Lv Y, Zhang F, Wang T, Wang X, Yuan W, Liu H, Huang J, Jiang Y, Liu N, Yang L, Hu Y, Li Y, Gao Y, Li H, Li B, Song C. Randomized trial of influence of vitamin D on the prevention and improvement of symptomatic COVID-19. Sci Rep. 2024 Sep 3;14(1):20519. doi: 10.1038/s41598-024-66267-8.
PubMed 39227626
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19
- ClinicalTrials.gov ID
- NCT05673980
- Acronym / sponsor ID
- M2022828
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 19 Jan 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 6 Jan 2023 (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.
A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks.
Detailed description
This study is a randomized controlled multicenter clinical trial. Participants who meet the inclusion criteria can be included in this trial after signing informed consent. A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks. Throughout the trial, participants' nucleic acid or antigen results, 25(OH)D concentrations, etc., need to be tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D2 | Experimental | Drug: Vitamin D2Oral dose of Vitamin D2 every two weeks |
| Placebo | Placebo comparator | Other: placeboWithout any intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to participate in the clinical study and sign the informed consent;
- Staff members of Peking University Third Hospital, including the hospital headquarters, Capital International Airport Hospital, North Hospital, Beijing Haidian Hospital, Peking University Third Hospital Yanqing Hospital and Peking University Third Hospital Chongli Hospital;
- Test negative for COVID-19 antigen and have no symptoms related to COVID-19.
Key exclusion criteria (4 listed)
- Hospital staff with serious underlying diseases;
- Pregnant and lactating women;
- Long-term vegetarians;
- Long-term chronic diarrhea, history of subtotal gastrectomy, biliary obstructive disease and pancreatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D2Also: cholecalciferolParticipants in the vitamin D2 group received 200,000 IU of vitamin D2 orally on the first day of the trial and again two weeks later | Drug | vitamin D2 |
| placeboThis group will not do any intervention | Other | Placebo |
Primary outcome
Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection
Time frame: 4 weeks
The test will be nucleic acid or antigen testing twice a week for four weeks
4 secondary outcomes
The duration of a positive to negative antigen test after infection with COVID-19
Time frame: up to 4 weeks
The duration of symptoms in COVID-19 positive participants
Time frame: up to 4 weeks
The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days
Time frame: 4 weeks
The proportion of asymptomatic COVID-19 infected persons (those who test positive for the etiology of COVID-19 but have no related clinical manifestations)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: PubMed 41341143Wang H, Liu H, Huang J, Meng X, Wang W, Xiao W, Liu D, Tao L, Song C. Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial. Clin Interv Aging. 2025 Nov 27;20:2219-2230. doi: 10.2147/CIA.S541940. eCollection 2025.
- Derived from this study: PubMed 39227626Wang H, Tao L, Cui L, Chen Y, Liu D, Xue L, Yang Y, Lv Y, Zhang F, Wang T, Wang X, Yuan W, Liu H, Huang J, Jiang Y, Liu N, Yang L, Hu Y, Li Y, Gao Y, Li H, Li B, Song C. Randomized trial of influence of vitamin D on the prevention and improvement of symptomatic COVID-19. Sci Rep. 2024 Sep 3;14(1):20519. doi: 10.1038/s41598-024-66267-8.
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Screening Protocol
Pain
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.
Chunli Song, Pro. contact
Chunli Song, Pro. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D2 in people with Healthy Volunteers, run by Peking University Third Hospital at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 2023. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Wang, Ms. (18251825313, wh18324178960@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05673980, which also lists 2 linked publications.
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 6 Jan 2023.