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Active, not recruitingNCT06232486Updated Jan 30, 2024

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

An observational study in Postherpetic Neuralgia, sponsored by Feng Gao. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Feng Gao · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
144
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Postherpetic Neuralgia

Keywords

  • Herpes zoster,post-herpes zoster,Vitamin D,
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's planned enrollment of 144 is above the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Feng Gao is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
144 participants (estimated)
Patient registry
No

Groups and cohorts

  • Herpes zoster patients

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

06

What researchers measure

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.

    Time frame: herpetic neuralgia <3 month

Secondary outcomes

  1. C-reactive protein

    An according to early infection stricture in serum.When CRP\>20mg/l is considered abnormally level .

    Time frame: Day 2 in the hospital

  2. Lymphocytes

    Lymphocytes is considered an label of virus infection when it outlier.

    Time frame: Day 2 in the hospital

  3. Red blood cell distribution width,RDM(fl)

    It is a reflects the inhomogeneity of red cell size.

    Time frame: Day 2 in the hospital

  4. Red blood cell count,RBC

    One of main recording to diagnosis of anemia . nomal mal (4-5.5)×10-12/L. nomal femal (3.5-5.0)×10-12/L.

    Time frame: Day 2 in the hospital

  5. Mean red cell volum,MVC

    It is a label of red cell size.normal range from 80 to 100fl.

    Time frame: Day 2 in the hospital

  6. Creatinine

    It is a metabolite of muscle and there are have many reasons induce creatinine rise,such as chronic or acute kidney damage,Medicine side effect.normal range:53-106umol/l.

    Time frame: Day 2 in the hospital

  7. Albumin

    It is a protein that is found in many animal tissues and serum.The normal range 35-50g/L.

    Time frame: Day 2 in the hospital

  8. Alkaline phosphatase

    Alkaline phosphatase (ALP or AKP) is an enzyme that is widely distributed in human liver, bone, intestine, kidney, placenta and other tissues and is excreted from the liver to the bile.normal male: 45\~125U/L;normal female:20\~49岁35\~100U/L

    Time frame: Day 2 in the hospital

  9. Uric acid

    Uric acid is the end product of purine metabolism. It is a trioxa purine, and its alcohol form is weakly acidic.normal male:150~416μmol/L,normal female:89~357μmolL

    Time frame: Day 2 in the hospital

  10. Blood glucose

    The production and utilization of blood sugar in normal people are in a state of dynamic balance, maintaining a relatively stable level, which is because the source and route of blood sugar are roughly the same result.Fasting blood-glucose(FBG):4.4\~6.1mmol/L。

    Time frame: Day 2 in the hospital

  11. diastolic blood pressure,

    An indicator in blood pressure measurement that indicates the pressure of the heart's arterial blood against the vessel walls during diastole. It is usually measured in millimeters of mercury (mmHg).

    Time frame: Day 2 in the hospital

  12. systolic blood pressure

    A type of blood pressure that refers to the pressure of blood against the artery walls when the heart contracts. It is often used as a measure of cardiovascular health(mmHg).

    Time frame: Day 2 in the hospital

  13. total cholesterol

    The sum of all cholesterol in the blood, including LDL cholesterol and HDL cholesterol. High levels of total cholesterol may increase the risk of cardiovascular disease.normal range:\<5.18mmol/L(\<200mg/dl)

    Time frame: Day 2 in the hospital

  14. triglycerides

    Triglyceride (TG) is a constituent of lipids, which is formed by glycerol and three fatty acids. normal range\<1.70mmol/L.

    Time frame: Day 2 in the hospital

  15. serum Ca2+ level

    Ionic calcium refers to the concentration of calcium ions in the blood, also known as serum calcium. Normal levels of ionic calcium maintain a stable range in the blood, generally 2.1-2.6 mmol/L(or 8.5-10.5 mg/dL).

    Time frame: Day 2 in the hospital

  16. Cellular immune indexes C3

    Complement C3 can promote phagocytic cells to move to promote phagocytosis, promote B cell proliferation, and have a solubilization effect on soluble immune complex.

    Time frame: Day 2 in the hospital

  17. Cellular immune indexes C4

    Complement C4 is an important component of the classical activation pathway of complement, which is divided into C4a and C4b. The release of C4a can induce mast cells to release histamine, increase the permeability of blood vessels and cause local exudative inflammation. C4b mainly plays a role in mediating the complement cascade, promoting phagocytosis, participating in preventing the deposition of immune complexes, and neutralizing viruses.

    Time frame: Day 2 in the hospital

  18. interleukin(IL)-10

    Interleukin-10 is a multi-cellular, multifunctional cytokine that regulates cell growth and differentiation, participates in inflammatory and immune responses, and is a recognized inflammatory and immunosuppressive factor.

    Time frame: Day 2 in the hospital

  19. interleukinIL-6

    The target cells of IL-6 action are many, including macrophages, hepatocytes, quiescent T cells, activated B cells and plasma cells.

    Time frame: Day 2 in the hospital

  20. interleukinIL-8

    Interleukin-8, or IL-8 for short, is a cytokine in the family of chemokines. Its role in participating in and regulating the physiological and pathological processes of human reproduction has been confirmed, and one of its mechanisms is to bind to its specific receptors.

    Time frame: Day 2 in the hospital

  21. tumor necrosis factor(TNF)-a

    TNF-α, also known as cachexin and TNFSF1A, is an adipokine involved in systemic inflammation and is one of the cytokines that stimulate the acute phase response. TNF-α transmits information to the nucleus through specific receptors on the cell membrane, thus producing complex biological activities such as promoting cell proliferation and differentiation, immune regulation, inflammation mediation, and anti-tumor.

    Time frame: Day 2 in the hospital

  22. Bone mineral density T value

    Bone mineral density T value,present the bone density to predict osteoporosis.

    Time frame: Day 2 in the hospital

  23. magnetic resonance imaging

    Results of MRI examination,exclude tumor or infection

    Time frame: Day 2 in the hospital

  24. cluster of differentiation 4(CD4)+

    CD4 cells, refers to the surface of the CD4+T molecule T lymphocytes, is an important immune cell in the human immune system, because the HIV attack object is CD4+T cells, so its detection results on the AIDS treatment effect and the judgment of the patient's immune function has an important role.

    Time frame: Day 2 in the hospital

  25. cluster of differentiation 8(CD8)+

    CD8+T cells generally refer to cytotoxic T lymphocytes. Cytotoxic T lymphocytes (CTL), a subdivision of white blood cells, are specific T cells that secrete various cytokines to participate in immune function.

    Time frame: Day 2 in the hospital

  26. numeric rating scale(NRS)

    The NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.

    Time frame: Day 2 in the hospital

  27. numeric rating scale(NRS)

    The NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.

    Time frame: After the therapy in hospital

  28. numeric rating scale(NRS)

    The NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.

    Time frame: After the therapy 1 month

  29. numeric rating scale(NRS)

    The NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.

    Time frame: After the therapy 2 month

  30. numeric rating scale(NRS)

    The NRS pain Score is an exponential scale that uses 0 to 10 to represent different levels of pain, 0 being painless and 10 being severe, and asks the patient how bad the pain is, or to circle a number that best represents their pain.

    Time frame: After the therapy 3 month

  31. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Time frame: Day 2 in the hospital

  32. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Time frame: After therapy in hospital

  33. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Time frame: After therapy 1 month

  34. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Time frame: After therapy 2 month

  35. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Time frame: After therapy 3 month

07

Study locations

1 site
  • Tongji Hospital
    Wuhan, Hubei 430030, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06232486
Lead sponsor
Feng Gao
Responsible party
Feng Gao (Professor, Tongji Hospital) — Sponsor-investigator
First posted
Jan 30, 2024
Start date
Dec 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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