Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

January 22, 2024 updated by: Feng Gao

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Herpes zoster patients
The patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum 25-hydroxyvitamin D levels
Time Frame: herpetic neuralgia <3 month
Vitamin D deficiency: < 20 nmol/L. Vitamin D deficiency: 20-30 nmol/L. Normal vitamin D: > 30 nmol/L.
herpetic neuralgia <3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: Day 2 in the hospital
An according to early infection stricture in serum.When CRP>20mg/l is considered abnormally level .
Day 2 in the hospital
Lymphocytes
Time Frame: Day 2 in the hospital
Lymphocytes is considered an label of virus infection when it outlier.
Day 2 in the hospital
Red blood cell distribution width,RDM(fl)
Time Frame: Day 2 in the hospital
It is a reflects the inhomogeneity of red cell size.
Day 2 in the hospital
Red blood cell count,RBC
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
Mean red cell volum,MVC
Time Frame: Day 2 in the hospital
It is a label of red cell size.normal range from 80 to 100fl.
Day 2 in the hospital
Creatinine
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
Albumin
Time Frame: Day 2 in the hospital
It is a protein that is found in many animal tissues and serum.The normal range 35-50g/L.
Day 2 in the hospital
Alkaline phosphatase
Time Frame: Day 2 in the hospital
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
Day 2 in the hospital
Uric acid
Time Frame: Day 2 in the hospital
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
Day 2 in the hospital
Blood glucose
Time Frame: Day 2 in the hospital
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。
Day 2 in the hospital
diastolic blood pressure,
Time Frame: Day 2 in the hospital
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).
Day 2 in the hospital
systolic blood pressure
Time Frame: Day 2 in the hospital
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).
Day 2 in the hospital
total cholesterol
Time Frame: Day 2 in the hospital
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）
Day 2 in the hospital
triglycerides
Time Frame: Day 2 in the hospital
Triglyceride (TG) is a constituent of lipids, which is formed by glycerol and three fatty acids. normal range<1.70mmol/L.
Day 2 in the hospital
serum Ca2+ level
Time Frame: Day 2 in the hospital
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).
Day 2 in the hospital
Cellular immune indexes C3
Time Frame: Day 2 in the hospital
Complement C3 can promote phagocytic cells to move to promote phagocytosis, promote B cell proliferation, and have a solubilization effect on soluble immune complex.
Day 2 in the hospital
Cellular immune indexes C4
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
interleukin(IL)-10
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
interleukinIL-6
Time Frame: Day 2 in the hospital
The target cells of IL-6 action are many, including macrophages, hepatocytes, quiescent T cells, activated B cells and plasma cells.
Day 2 in the hospital
interleukinIL-8
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
tumor necrosis factor(TNF)-a
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
Bone mineral density T value
Time Frame: Day 2 in the hospital
Bone mineral density T value,present the bone density to predict osteoporosis.
Day 2 in the hospital
magnetic resonance imaging
Time Frame: Day 2 in the hospital
Results of MRI examination,exclude tumor or infection
Day 2 in the hospital
cluster of differentiation 4(CD4)+
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
cluster of differentiation 8(CD8)+
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
numeric rating scale(NRS)
Time Frame: Day 2 in the hospital
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.
Day 2 in the hospital
numeric rating scale(NRS)
Time Frame: After the therapy in hospital
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.
After the therapy in hospital
numeric rating scale(NRS)
Time Frame: After the therapy 1 month
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.
After the therapy 1 month
numeric rating scale(NRS)
Time Frame: After the therapy 2 month
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.
After the therapy 2 month
numeric rating scale(NRS)
Time Frame: After the therapy 3 month
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.
After the therapy 3 month
DN4
Time Frame: Day 2 in the hospital
A table of pain assesment that mainly about neuropathic pain.
Day 2 in the hospital
DN4
Time Frame: After therapy in hospital
A table of pain assesment that mainly about neuropathic pain.
After therapy in hospital
DN4
Time Frame: After therapy 1 month
A table of pain assesment that mainly about neuropathic pain.
After therapy 1 month
DN4
Time Frame: After therapy 2 month
A table of pain assesment that mainly about neuropathic pain.
After therapy 2 month
DN4
Time Frame: After therapy 3 month
A table of pain assesment that mainly about neuropathic pain.
After therapy 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Feng Gao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TJ-IRB20231251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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