CClinicalTrials.gg
Status unknownNCT05673980Updated Jan 6, 2023

Oral Vitamin D2 for Prevention of COVID-19

An interventional study of Vitamin D2 and placebo in Healthy Volunteers, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Willing to participate in the clinical study and sign the informed consent;
  2. 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;
  3. Test negative for COVID-19 antigen and have no symptoms related to COVID-19.

Exclusion criteria

Exclusion Criteria:

  1. Hospital staff with serious underlying diseases;
  2. Pregnant and lactating women;
  3. Long-term vegetarians;
  4. Long-term chronic diarrhea, history of subtotal gastrectomy, biliary obstructive disease and pancreatic disease.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
218 participants (estimated)

Study arms

  • Experimental
    vitamin D2

    Oral dose of Vitamin D2 every two weeks

    Drug: Vitamin D2

  • Placebo comparator
    Placebo

    Without any intervention

    Other: placebo

Interventions

  • DrugVitamin D2

    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

    Also known as: cholecalciferol

  • Otherplacebo

    This group will not do any intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 weeks

Secondary outcomes

  1. 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

    Time frame: up to 4 weeks

  2. The duration of symptoms in COVID-19 positive participants

    For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.

    Time frame: up to 4 weeks

  3. 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.

    Time frame: 4 weeks

  4. 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.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    • Huan Wang, Ms. · Contact · wh18324178960@163.com · 18251825313
    • Chunli Song, Pro. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05673980
Lead sponsor
Peking University Third Hospital
Collaborators
Beijing Haidian Hospital
Responsible party
Sponsor
First posted
Jan 6, 2023
Start date
Dec 18, 2022
Primary completion
Jan 19, 2023 (estimated)
Completion
Feb 20, 2023 (estimated)
Last update
Jan 6, 2023

Study contacts

Huan Wang, Ms.
Contact
wh18324178960@163.com
18251825313
Chunli Song, Pro.
Contact
schl@bjmu.edu.cn
Chunli Song, Pro.
study chair · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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