Impact of COVID-19 Vaccination on Serum 25-hydroxyvitamin D Level

NCT ID: NCT05398939

Last Updated: 2024-04-16

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-25

Study Completion Date

2022-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Vitamin D plays a pivotal but still not well understood role in the immune response to coronavirus disease (COVID-19) infection and vaccination. Many studies also showed a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels. Patients with acne vulgaris often had deteriorated skin condition after COVID-19 vaccination. Therefore, this study aimed to investigate the relationship of COVID-19 vaccination with serum 25-hydroxyvitamin D level and severity of acne vulgaris.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vitamin D is known to be related with calcium and bone metabolism. Recently, vitamin D has been shown to play an important role in innate and acquired immunity, cytokine release, inflammatory response, and may be associated with a reduced risk of infection. Studies have reported that serum 25-hydroxyvitamin D concentrations are significantly lower in COVID-19 infected patients than in uninfected patients. In addition, it has been shown that people with higher serum 25-hydroxyvitamin D level would produce significantly more antibodies after COVID-19 vaccination.Thus, it is clear that vitamin D plays a pivotal but still not well understood role in the immune response to COVID-19 infection and vaccination.

Patients with inflammatory skin diseases (e.g., psoriasis, atopic dermatitis, acne vulgaris, hair loss, idiopathic urticaria, etc.) are often observed to have deteriorated skin condition after COVID-19 vaccination, which not only affects the patient's quality of life, but also seriously affects the patient's willingness to complete vaccination. Since many studies have shown a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels, it is likely that the COVID-19 vaccination also impacts serum 25-hydroxyvitamin D levels. Therefore, this study aimed to analyze the changes in serum 25-hydroxyvitamin D levels and acne severity in patients with acne vulgaris before and after the third dose of COVID-19 vaccine.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acne Vulgaris Vitamin D Deficiency COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acne cohort

Adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine.

Blood test and skin evaluation

Intervention Type DIAGNOSTIC_TEST

The patients received blood tests for serum 25-hydroxyvitamin D level and skin evaluation for severity of acne vulgaris and lesion counts.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood test and skin evaluation

The patients received blood tests for serum 25-hydroxyvitamin D level and skin evaluation for severity of acne vulgaris and lesion counts.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age of ≥ 20 years and \< 65 years
2. Diagnosis of acne vulgaris
3. The one will receive the third dose of COVID-19 vaccine
4. Signing informed consent

Exclusion Criteria

1. History of COVID-19 infection
2. Currently taking vitamin-D, steroid, or any drugs for acne vulgaris.
3. Coagulopathy
4. Having any chronic inflammation disease, immunity-related disease, diabetes, mellitus, kidney disease, or liver disease.
5. Have acute inflammation disease, for example, upper respiratory infection or urinary tract infection
6. Pregnancy or lactation
7. History of cancer or any major systematic disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chih-Chieh Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Dermatology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202204118RINC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral 25-hydroxyvitamin D3 and COVID-19
NCT04386850 UNKNOWN PHASE2/PHASE3
The Effect of Vitamin D on Fertility
NCT03890458 COMPLETED PHASE4