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.
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.
About this study
Official title: Association Between Serum Vitamin D and Postherpetic Neuralgia, A Prospective Observation Study.
- 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.
- 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.
- Conditions
- Postherpetic Neuralgia
- 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 group | Role | What they receive |
|---|---|---|
| Herpes zoster patients | The 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.
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)
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
Lymphocytes
Lymphocytes is considered an label of virus infection when it outlier.
Measured: Day 2 in the hospital
Red blood cell distribution width,RDM(fl)
It is a reflects the inhomogeneity of red cell size.
Measured: Day 2 in the hospital
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Bone mineral density T value
Bone mineral density T value,present the bone density to predict osteoporosis.
Measured: Day 2 in the hospital
magnetic resonance imaging
Results of MRI examination,exclude tumor or infection
Measured: Day 2 in the hospital
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
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
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
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
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
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
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
DN4
A table of pain assesment that mainly about neuropathic pain.
Measured: Day 2 in the hospital
DN4
A table of pain assesment that mainly about neuropathic pain.
Measured: After therapy in hospital
DN4
A table of pain assesment that mainly about neuropathic pain.
Measured: After therapy 1 month
DN4
A table of pain assesment that mainly about neuropathic pain.
Measured: After therapy 2 month
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.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Tongji Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Vitamin D and Postherpetic Neuralgia, A Prospective Observation Study.
- ClinicalTrials.gov ID
- NCT06232486
- Acronym / sponsor ID
- TJ-IRB20231251
- Conditions
- Postherpetic Neuralgia
- Keywords
- Herpes zoster,post-herpes zoster,Vitamin D,
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herpes zoster patients | – | –The patient was diagnosed with herpetic neuralgia and the course of disease was ≤3 months; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
35 secondary outcomes
C-reactive protein
Time frame: Day 2 in the hospital
Lymphocytes
Time frame: Day 2 in the hospital
Red blood cell distribution width,RDM(fl)
Time frame: Day 2 in the hospital
Red blood cell count,RBC
Time frame: Day 2 in the hospital
Mean red cell volum,MVC
Time frame: Day 2 in the hospital
Creatinine
Time frame: Day 2 in the hospital
Albumin
Time frame: Day 2 in the hospital
Alkaline phosphatase
Time frame: Day 2 in the hospital
Uric acid
Time frame: Day 2 in the hospital
Blood glucose
Time frame: Day 2 in the hospital
diastolic blood pressure,
Time frame: Day 2 in the hospital
systolic blood pressure
Time frame: Day 2 in the hospital
total cholesterol
Time frame: Day 2 in the hospital
triglycerides
Time frame: Day 2 in the hospital
serum Ca2+ level
Time frame: Day 2 in the hospital
Cellular immune indexes C3
Time frame: Day 2 in the hospital
Cellular immune indexes C4
Time frame: Day 2 in the hospital
interleukin(IL)-10
Time frame: Day 2 in the hospital
interleukinIL-6
Time frame: Day 2 in the hospital
interleukinIL-8
Time frame: Day 2 in the hospital
tumor necrosis factor(TNF)-a
Time frame: Day 2 in the hospital
Bone mineral density T value
Time frame: Day 2 in the hospital
magnetic resonance imaging
Time frame: Day 2 in the hospital
cluster of differentiation 4(CD4)+
Time frame: Day 2 in the hospital
cluster of differentiation 8(CD8)+
Time frame: Day 2 in the hospital
numeric rating scale(NRS)
Time frame: Day 2 in the hospital
numeric rating scale(NRS)
Time frame: After the therapy in hospital
numeric rating scale(NRS)
Time frame: After the therapy 1 month
numeric rating scale(NRS)
Time frame: After the therapy 2 month
numeric rating scale(NRS)
Time frame: After the therapy 3 month
DN4
Time frame: Day 2 in the hospital
DN4
Time frame: After therapy in hospital
DN4
Time frame: After therapy 1 month
DN4
Time frame: After therapy 2 month
DN4
Time frame: After therapy 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Postherpetic Neuralgia
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Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
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Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.