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临床试验/NCT06232486
NCT06232486进行中(未招募)不适用

Association Between Serum Vitamin D and Postherpetic Neuralgia, A Prospective Observation Study.

Feng Gao1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
144
试验地点
1
主要终点
Serum 25-hydroxyvitamin D levels

研究概览

简要总结

  1. The correlations of serum vitamin D level, serum calcium level and osteoporosis degree with disease severity, treatment response, incidence of Post-Herpes zoster(PHN) and disease prognosis in Herpes zoster(HZ) patients were studied.
  2. To investigate the role of inflammation-related factors and immune-related factors in the occurrence and development of HZ mediated by low vitamin D level.

详细描述

Herpes zoster is a neuropathic disease which induce by the varicella-herpes virus reactivation.and postherpetic neuralgia (PHN) is the most common complication. Currently,the mechanism of herpes zoster still unclearly even though there had much study about it .Vitamin D is an essential vitamin for human body, which has the function of maintaining calcium and phosphorus homeostasis and immune regulation. Vitamin D is a natural antiviral substance, and vitamin D deficiency can affect the body's antiviral ability, thereby promoting varicella-zoster virus(VZV) reactivation, and may promote the development of PHN through continuous neuroinflammation. Therefore, vitamin D level may be related to the occurrence and progression of HZ. this study intends to use an observational cohort study design to investigate the correlation of serum vitamin D level and osteoporosis degree with the severity of the herpes zoster disease, Although we plan to further explore the role of inflammatory state in this process.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years.
  • The patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months.
  • Can cooperate with the completion of inquiry and scale evaluation.

排除标准

  • Severe spinal disease (fracture, malignancy, acute or chronic infection) confirmed by previous spinal surgery or imaging.
  • Previous history of head trauma.
  • Have autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, leucothrombocytopenia).
  • Suffering from mental disorders, intellectual disability, epilepsy and other diseases.
  • A history of substance abuse, drug abuse or alcohol abuse.
  • Pregnant or breastfeeding women.
  • And recent participation in other clinical studies.

结局指标

主要结局

Serum 25-hydroxyvitamin D levels

时间窗: herpetic neuralgia <3 month

Vitamin D deficiency: \< 20 nmol/L. Vitamin D deficiency: 20-30 nmol/L. Normal vitamin D: \> 30 nmol/L.

次要结局

  • C-reactive protein(Day 2 in the hospital)
  • Lymphocytes(Day 2 in the hospital)
  • Red blood cell distribution width,RDM(fl)(Day 2 in the hospital)
  • Mean red cell volum,MVC(Day 2 in the hospital)
  • Red blood cell count,RBC(Day 2 in the hospital)
  • Blood glucose(Day 2 in the hospital)
  • interleukinIL-8(Day 2 in the hospital)
  • diastolic blood pressure,(Day 2 in the hospital)
  • triglycerides(Day 2 in the hospital)
  • interleukin(IL)-10(Day 2 in the hospital)
  • Creatinine(Day 2 in the hospital)
  • Uric acid(Day 2 in the hospital)
  • Albumin(Day 2 in the hospital)
  • tumor necrosis factor(TNF)-a(Day 2 in the hospital)
  • cluster of differentiation 4(CD4)+(Day 2 in the hospital)
  • DN4(After therapy 3 month)
  • Alkaline phosphatase(Day 2 in the hospital)
  • systolic blood pressure(Day 2 in the hospital)
  • total cholesterol(Day 2 in the hospital)
  • Cellular immune indexes C4(Day 2 in the hospital)
  • magnetic resonance imaging(Day 2 in the hospital)
  • cluster of differentiation 8(CD8)+(Day 2 in the hospital)
  • serum Ca2+ level(Day 2 in the hospital)
  • Cellular immune indexes C3(Day 2 in the hospital)
  • interleukinIL-6(Day 2 in the hospital)
  • Bone mineral density T value(Day 2 in the hospital)
  • numeric rating scale(NRS)(After the therapy 3 month)

研究者

发起方
Feng Gao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Gao

Professor

Tongji Hospital

研究点 (1)

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