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临床试验/NCT05398939
NCT05398939已完成不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in serum 25-hydroxyvitamin D level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in serum 25-hydroxyvitamin D level

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

Blood test for serum 25-hydroxyvitamin D level

次要结局

  • Change in acne acne lesion counts(7 days before and 28 days after the third dose of COVID-10 vaccine)
  • Change in acne severity(7 days before and 28 days after the third dose of COVID-10 vaccine)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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