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Postherpetic NeuralgiaNCT06232486

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

An observational study of Postherpetic Neuralgia, run by Feng Gao at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postherpetic Neuralgia
How many people
144 participants
Where
1 siteChina
Study dates
1 Dec 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Tongji Hospital

    Wuhan, Hubei, 430030

Other trials in China

About this study

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

  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.

Keywords
Herpes zoster,post-herpes zoster,Vitamin D,
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06232486
Study groupRoleWhat they receive
Herpes zoster patientsThe patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months;

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: herpetic neuralgia <3 month

Secondary outcomes (35)
  1. C-reactive protein

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

    Measured: Day 2 in the hospital

  2. Lymphocytes

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

    Measured: Day 2 in the hospital

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

    It is a reflects the inhomogeneity of red cell size.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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。

    Measured: 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).

    Measured: 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).

    Measured: 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)

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Day 2 in the hospital

  22. Bone mineral density T value

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

    Measured: Day 2 in the hospital

  23. magnetic resonance imaging

    Results of MRI examination,exclude tumor or infection

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: After the therapy 3 month

  31. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Measured: Day 2 in the hospital

  32. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Measured: After therapy in hospital

  33. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Measured: After therapy 1 month

  34. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Measured: After therapy 2 month

  35. DN4

    A table of pain assesment that mainly about neuropathic pain.

    Measured: After therapy 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Dec 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232486
Sponsor's protocol ID
TJ-IRB20231251
Status last verified
Jan 2024
First submitted
25 Dec 2023
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postherpetic Neuralgia, run by Feng Gao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum 25-hydroxyvitamin D levels (time frame: herpetic neuralgia <3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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