Oral Vitamin D2 for Prevention of COVID-19

NCT ID: NCT05673980

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-18

Study Completion Date

2023-02-20

Brief Summary

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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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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vitamin D2

Oral dose of Vitamin D2 every two weeks

Group Type EXPERIMENTAL

Vitamin D2

Intervention Type DRUG

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

Placebo

Without any intervention

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

This group will not do any intervention

Interventions

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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

Intervention Type DRUG

placebo

This group will not do any intervention

Intervention Type OTHER

Other Intervention Names

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cholecalciferol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chunli Song, Pro.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huan Wang, Ms.

Role: CONTACT

18251825313

Chunli Song, Pro.

Role: CONTACT

Facility Contacts

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Huan Wang, Ms.

Role: primary

18251825313 ext. +86

References

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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.

Reference Type DERIVED
PMID: 39227626 (View on PubMed)

Other Identifiers

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M2022828

Identifier Type: -

Identifier Source: org_study_id

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