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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05398939
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris; Vitamin D Deficiency; COVID-19	Diagnostic Test: Blood test and skin evaluation

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Impact of COVID-19 Vaccination on Serum 25-hydroxyvitamin D Level
• Actual Study Start Date: Jun 6, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acne cohort Adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Change in acne acne lesion counts [7 days before and 28 days after the third dose of COVID-10 vaccine]

   Counts of acne lesion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Chih-Chieh Chan, MD, Department of Dermatology, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT05398939
• Other Study ID Numbers: 202204118RINC
• First Posted: Jun 1, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Acne Vulgaris; Vitamin D Deficiency

Study Results

No Results Posted as of Jun 9, 2022