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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05398939
• Other study ID #: 202204118RINC
• Status: Completed
• Start date: May 25, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 29, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris
• COVID-19
• Vitamin D Deficiency

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Dermatology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum 25-hydroxyvitamin D level	Blood test for serum 25-hydroxyvitamin D level	7 days before and 28 days after the third dose of COVID-10 vaccine
Secondary	Change in acne severity	Skin evaluation by the Global Acne Grading System	7 days before and 28 days after the third dose of COVID-10 vaccine
Secondary	Change in acne acne lesion counts	Counts of acne lesion	7 days before and 28 days after the third dose of COVID-10 vaccine