Clinical trial NCT05673980: Oral Vitamin D2 for Prevention of COVID-19
Official title: A Randomized Controlled Clinical Trial of Oral Vitamin D2 for the Prevention of COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Haidian Hospital
First posted: 2023-01-06
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in incidence of laboratory-confirmed (or COVID-19 antibody test) COVID-19 infection
timeFrame: 4 weeks
Secondary outcomes:
measure: The duration of a positive to negative antigen test after infection with COVID-19
timeFrame: up to 4 weeks
measure: The duration of symptoms in COVID-19 positive participants
timeFrame: up to 4 weeks
measure: The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days
timeFrame: 4 weeks
measure: The proportion of asymptomatic COVID-19 infected persons (those who test positive for the etiology of COVID-19 but have no related clinical manifestations)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Chunli Song, Pro.
role: STUDY_CHAIR
References: