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

Completed

• Conditions: Acne Vulgaris; Vitamin D Deficiency; COVID-19
• Interventions: Diagnostic Test: Blood test and skin evaluation

• Registration Number: NCT05398939
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-01
• Primary Completion: 2022-07-04
• Study Completion: 2022-11-29
• Status Verified: 2023-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acne cohort	Blood test and skin evaluation	Adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine.

Primary Outcome Measures

Name	Time	Method
Change in serum 25-hydroxyvitamin D level	7 days before and 28 days after the third dose of COVID-10 vaccine	Blood test for serum 25-hydroxyvitamin D level

Secondary Outcome Measures

Name	Time	Method
Change in acne acne lesion counts	7 days before and 28 days after the third dose of COVID-10 vaccine	Counts of acne lesion
Change in acne severity	7 days before and 28 days after the third dose of COVID-10 vaccine	Skin evaluation by the Global Acne Grading System

Trial Locations

Locations (1)

Department of Dermatology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan