Oral Vitamin D2 for Prevention of COVID-19

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Vitamin D2; Other: placebo

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 Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunli Song, Pro.; Email: schl@bjmu.edu.cn
• Study Contact Backup: Name: Huan Wang, Ms.; Phone Number: 18251825313; Email: wh18324178960@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Huan Wang, Ms.; Phone Number: +86 18251825313; Email: wh18324178960@163.com
      • Principal Investigator: Chunli Song, Pro.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin D2; Oral dose of Vitamin D2 every two weeks	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 Names: cholecalciferol
Placebo Comparator: Placebo; Without any intervention	Other: placebo; This group will not do any intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Haidian Hospital
• Investigators: Study Chair: Chunli Song, Pro., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2022
• Primary Completion (Anticipated): January 19, 2023
• Study Completion (Anticipated): February 20, 2023

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Estimate): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: M2022828

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No