NCT05673980

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

January 6, 2023

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

December 30, 2022

Last Update Submit

December 30, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • The duration of a positive to negative antigen test after infection with COVID-19

    up to 4 weeks

  • The duration of symptoms in COVID-19 positive participants

    up to 4 weeks

  • The proportion of participants whose symptoms of COVID-19 infection were confirmed by antigen testing for more than 7 days

    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)

    4 weeks

Study Arms (2)

vitamin D2

EXPERIMENTAL

Oral dose of Vitamin D2 every two weeks

Drug: Vitamin D2

Placebo

PLACEBO COMPARATOR

Without any intervention

Other: placebo

Interventions

Vitamin D2DRUG

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

Also known as: cholecalciferol
vitamin D2
placeboOTHER

This group will not do any intervention

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

  • Wang H, Liu H, Huang J, Meng X, Wang W, Xiao W, Liu D, Tao L, Song C. Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial. Clin Interv Aging. 2025 Nov 27;20:2219-2230. doi: 10.2147/CIA.S541940. eCollection 2025.

    PMID: 41341143DERIVED

  • Wang H, Tao L, Cui L, Chen Y, Liu D, Xue L, Yang Y, Lv Y, Zhang F, Wang T, Wang X, Yuan W, Liu H, Huang J, Jiang Y, Liu N, Yang L, Hu Y, Li Y, Gao Y, Li H, Li B, Song C. Randomized trial of influence of vitamin D on the prevention and improvement of symptomatic COVID-19. Sci Rep. 2024 Sep 3;14(1):20519. doi: 10.1038/s41598-024-66267-8.

    PMID: 39227626DERIVED

MeSH Terms

Interventions

ErgocalciferolsCholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Chunli Song, Pro.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Huan Wang, Ms.

CONTACT

18251825313wh18324178960@163.com

Chunli Song, Pro.

CONTACT

schl@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

December 18, 2022

Primary Completion

January 19, 2023

Study Completion

February 20, 2023

Last Updated

January 6, 2023

Record last verified: 2022-12

Locations

CN(1)