Oral Vitamin D2 for Prevention of COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Vitamin D2
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D2<br>Oral dose of Vitamin D2 every two weeks | Drug: Vitamin D2<br>* 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<br>* Other names: cholecalciferol;|
| Placebo Comparator: Placebo<br>Without any intervention | Other: placebo<br>* This group will not do any intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 4 weeks |