Clinical trial NCT06232486: Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.
Official title: Association Between Serum Vitamin D and Postherpetic Neuralgia, A Prospective Observation Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postherpetic Neuralgia
Keywords: Herpes zoster,post-herpes zoster,Vitamin D,
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with herpes zoster who were hospitalized in the Department of Pain Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from October 2023 to October 2025 were selected.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum 25-hydroxyvitamin D levels
timeFrame: herpetic neuralgia <3 month
Secondary outcomes:
measure: C-reactive protein
timeFrame: Day 2 in the hospital
measure: Lymphocytes
timeFrame: Day 2 in the hospital
measure: Red blood cell distribution width,RDM(fl)
timeFrame: Day 2 in the hospital
measure: Red blood cell count,RBC
timeFrame: Day 2 in the hospital
measure: Mean red cell volum,MVC
timeFrame: Day 2 in the hospital
measure: Creatinine
timeFrame: Day 2 in the hospital
measure: Albumin
timeFrame: Day 2 in the hospital
measure: Alkaline phosphatase
timeFrame: Day 2 in the hospital
measure: Uric acid
timeFrame: Day 2 in the hospital
measure: Blood glucose
timeFrame: Day 2 in the hospital
measure: diastolic blood pressure,
timeFrame: Day 2 in the hospital
measure: systolic blood pressure
timeFrame: Day 2 in the hospital
measure: total cholesterol
timeFrame: Day 2 in the hospital
measure: triglycerides
timeFrame: Day 2 in the hospital
measure: serum Ca2+ level
timeFrame: Day 2 in the hospital
measure: Cellular immune indexes C3
timeFrame: Day 2 in the hospital
measure: Cellular immune indexes C4
timeFrame: Day 2 in the hospital
measure: interleukin(IL)-10
timeFrame: Day 2 in the hospital
measure: interleukinIL-6
timeFrame: Day 2 in the hospital
measure: interleukinIL-8
timeFrame: Day 2 in the hospital
measure: tumor necrosis factor(TNF)-a
timeFrame: Day 2 in the hospital
measure: Bone mineral density T value
timeFrame: Day 2 in the hospital
measure: magnetic resonance imaging
timeFrame: Day 2 in the hospital
measure: cluster of differentiation 4(CD4)+
timeFrame: Day 2 in the hospital
measure: cluster of differentiation 8(CD8)+
timeFrame: Day 2 in the hospital
measure: numeric rating scale(NRS)
timeFrame: Day 2 in the hospital
measure: numeric rating scale(NRS)
timeFrame: After the therapy in hospital
measure: numeric rating scale(NRS)
timeFrame: After the therapy 1 month
measure: numeric rating scale(NRS)
timeFrame: After the therapy 2 month
measure: numeric rating scale(NRS)
timeFrame: After the therapy 3 month
measure: DN4
timeFrame: Day 2 in the hospital
measure: DN4
timeFrame: After therapy in hospital
measure: DN4
timeFrame: After therapy 1 month
measure: DN4
timeFrame: After therapy 2 month
measure: DN4
timeFrame: After therapy 3 month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: