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

NCT05398939 | Completed

• 1 other identifier: 202204118RINC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris; Vitamin D Deficiency; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in acne severity

  7 days before and 28 days after the third dose of COVID-10 vaccine

• Change in acne acne lesion counts

  7 days before and 28 days after the third dose of COVID-10 vaccine

Study Arms (1)

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

Interventions

Blood test and skin evaluation DIAGNOSTIC_TEST

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

Acne cohort

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• History of COVID-19 infection
• Currently taking vitamin-D, steroid, or any drugs for acne vulgaris.
• Coagulopathy
• Having any chronic inflammation disease, immunity-related disease, diabetes, mellitus, kidney disease, or liver disease.
• Have acute inflammation disease, for example, upper respiratory infection or urinary tract infection
• Pregnancy or lactation
• History of cancer or any major systematic disease

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Dermatology, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Acne Vulgaris; Vitamin D Deficiency; COVID-19

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Chih-Chieh Chan, MD

  Department of Dermatology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 1, 2022
• Study Start: May 25, 2022
• Primary Completion: July 4, 2022
• Study Completion: November 29, 2022
• Last Updated: April 16, 2024

Record last verified: 2023-04

Locations

TW (1)