Oral Vitamin D2 for Prevention of COVID-19

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Other: placebo; Drug: Vitamin D2

• Registration Number: NCT05673980
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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 Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-18
• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Last Update Submitted: 2022-12-30
• Study First Posted: 2023-01-06
• Last Update Posted: 2023-01-06
• Primary Completion: 2023-01-19
• Study Completion: 2023-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 218

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Without any intervention
vitamin D2	Vitamin D2	Oral dose of Vitamin D2 every two weeks

Primary Outcome Measures

Name	Time	Method
Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection	4 weeks	The test will be nucleic acid or antigen testing twice a week for four weeks

Secondary Outcome Measures

Name	Time	Method
The duration of a positive to negative antigen test after infection with COVID-19	up to 4 weeks	Antigen test results were recorded twice a week for four weeks
The duration of symptoms in COVID-19 positive participants	up to 4 weeks	For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.
The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days	4 weeks	For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.
The proportion of asymptomatic COVID-19 infected persons (those who test positive for the etiology of COVID-19 but have no related clinical manifestations)	4 weeks	For COVID-19 positive participants, symptoms will be recorded on a questionnaire twice a week.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China