NCT06232486

Brief Summary

  1. 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

December 25, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

Herpes zoster,post-herpes zoster,Vitamin D,

Outcome Measures

Primary Outcomes (1)

  • Serum 25-hydroxyvitamin D levels

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

    herpetic neuralgia <3 month

Secondary Outcomes (35)

  • 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

  • Red blood cell count,RBC

    Day 2 in the hospital

  • Mean red cell volum,MVC

    Day 2 in the hospital

  • +30 more secondary outcomes

Study Arms (1)

Herpes zoster patients

The patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months;

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 30, 2024

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations