Oral Vitamin D2 for Prevention of COVID-19

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673980
• Other study ID #: M2022828
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: December 2022
• Source: Peking University Third Hospital
• Contact: Huan Wang, Ms.
• Phone: 18251825313
• Email: wh18324178960[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: February 20, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Vitamin 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

Other:
• placebo
This group will not do any intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Haidian Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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