MigraineNCT06304948
The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency
An observational study of Migraine, run by Assiut University.
Trial summary
1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks 2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine. 3. To correlate the serum level of glutamate with gene expression of in migraine Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Feb 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria. And The age of the selected patients ranged between 15 and 55 years of both sexes
Who may be able to join
- Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria.
- The age of the selected patients ranged between 15 and 55 years of both sexes
- Able to give informed consent.
Who cannot join
- b. Exclusion criteria:
- presence of neurological disease other than migraine
- presence of other chronic medical conditions
- Participants in both groups were excluded from the study if they consumed vitamin D supplements in the preceding 3 months (any dose); or if they were taking medications that could affect vitamin D serum level such as glucocorticoids, thiazide diuretics, or statins. 4)patients refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Link Between Human Cytomegalovirus Gene Expression and Glutamate Levels in Migraine :Relationship to the Vit D Deficiency
- To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks
- To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.
- To correlate the serum level of glutamate with gene expression of in migraine
Read the detailed description
According to the report of global burden of disease (GBD) 2016, migraine headache has been established as the leading disability cause in the globe among under 50 years old [1]. It has been estimated that migraine affects about 11% of adults with a major impact on those aged between 25 to 55 years, which consequently lead to the high headache burden on individuals, communities, health care systems, and societies. Migraine is 2-3 times more common in women than in men. Migraine attacks are usually more prolonged, with higher intensity and more disability among females.
Current pharmacological treatments for migraine demonstrated limited efficacy in some patients and commonly lead to some adverse events such as weight reduction or weight gain, fatigue/sleepiness, sweating, night dreams, gastrointestinal upset and hypotension or reduced concentration. Novel therapeutic approaches of nutritional agents have become the promising strategies to alleviate symptoms of migraine. Vitamin D, one of the dietary agents, has revealed some potential in managing pain and migraine.
Cytomegalovirus (CMV) contamination is one of the clinically most critical irresistible complications of solid-organ transplantation. CMV disease, characterized as a critical rise within the titer of CMV-specific antibodies, happens in 44 % to 85% of kidney, heart, and liver transplant recipients - basically within the to begin with 3 months post transplantation, when immunosuppression is most intense. CMV malady shows in transplant beneficiaries essentially within the organ transplanted with the chance of successive dispersal and disability of other organs such as the central-nervous system, eye, and urogenital- or gastrointestinal tract. Additionally, dynamic CMV disease could be a noteworthy autonomous indicator of intense unite dismissal and event of artful contaminations.
Join brokenness and dismissal are related with vitamin D (VD) lack. In patients with end-stage organ disappointment anticipating transplant, VD lacking and lack are greatly common. Inadequately levels of vitamin D metabolites (25-hydroxyvitamin D [25(OH)D3] and 1,25-hydroxyvitamin D [1a,25_ Dihydroxyvitamin D3] have been detailed for patients with terminal congestive heart disappointment. pneumonic infection, liver disappointment [5], and incessant kidney illness.
in the past few years, there has been increasing interest in the complex interplay between vitamin D and infectious pathogens 7 Vitamin D supplementation is beneficial for patients with HIV, hepatitis C virus, Chlamydia spp. or mycobacterial infection. A significant reduction in the risk of CMV infection and disease by vitamin D supplementation would be highly attractive because of a high therapeutic index of vitamin D, the ease of application (oral solutions), and added benefits such as improved musculoskeletal health. Contrary to expectation, we found that CMV infection interferes with the vitamin D system of mammalian cells.
CMV infection downregulated vitamin D receptor expression and this downregulation was specific for CMV and was not observed for other, common human viruses. This observation may have far-reaching virological, immunological, and clinical implication
The aim of the present study was to assess a possible effect of migraine in patients with CMV infection on vit D levels and Glutamate levels to combine existing knowledge about the role of glutamate in migraine pathogenesis along with information on nutrients that are protective against glutamate excitotoxicity, and then end with a proposed dietary treatment for migraine management.
There is an obvious gap between our understanding of migraines and the dietary strategies which have been administered so far, since dietary nutrients are often studied separately, and no specific diet for migraine has been developed. However, the beneficial effects of the low glutamate diet on widespread chronic pain disorders appear to have overlapping mechanistic effects, and additionally is some preliminary evidence supporting an effect on migraine. Thus, further research on this dietary strategy in migraine is warranted
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency
Relation between CMV infection and glutamate level in patients with migraine in relation to vitamin D level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 72 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Omar Ali, Assiut University
- Investigators
- Essam S Darweish, Study director, Assuit u
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304948
- Sponsor's protocol ID
- Vitamin D and migraine
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018 Feb 21;19(1):17. doi: 10.1186/s10194-018-0846-2. No abstract available.
PubMed 29468450Steininger C. Clinical relevance of cytomegalovirus infection in patients with disorders of the immune system. Clin Microbiol Infect. 2007 Oct;13(10):953-63. doi: 10.1111/j.1469-0691.2007.01781.x.
PubMed 17803749Hartmann A, Sagedal S, Hjelmesaeth J. The natural course of cytomegalovirus infection and disease in renal transplant recipients. Transplantation. 2006 Jul 27;82(2 Suppl):S15-7. doi: 10.1097/01.tp.0000230460.42558.b0.
PubMed 16858268Monegal A, Navasa M, Guanabens N, Peris P, Pons F, Martinez de Osaba MJ, Rimola A, Rodes J, Munoz-Gomez J. Bone mass and mineral metabolism in liver transplant patients treated with FK506 or cyclosporine A. Calcif Tissue Int. 2001 Feb;68(2):83-6. doi: 10.1007/BF02678145.
PubMed 11310351Latic N, Erben RG. Vitamin D and Cardiovascular Disease, with Emphasis on Hypertension, Atherosclerosis, and Heart Failure. Int J Mol Sci. 2020 Sep 4;21(18):6483. doi: 10.3390/ijms21186483.
PubMed 32899880Gallo D, Mortara L, Gariboldi MB, Cattaneo SAM, Rosetti S, Gentile L, Noonan DM, Premoli P, Cusini C, Tanda ML, Bartalena L, Piantanida E. Immunomodulatory effect of vitamin D and its potential role in the prevention and treatment of thyroid autoimmunity: a narrative review. J Endocrinol Invest. 2020 Apr;43(4):413-429. doi: 10.1007/s40618-019-01123-5. Epub 2019 Oct 4.
PubMed 31584143Kearns MD, Alvarez JA, Seidel N, Tangpricha V. Impact of vitamin D on infectious disease. Am J Med Sci. 2015 Mar;349(3):245-62. doi: 10.1097/MAJ.0000000000000360.
PubMed 25334038Wells RE, Beuthin J, Granetzke L. Complementary and Integrative Medicine for Episodic Migraine: an Update of Evidence from the Last 3 Years. Curr Pain Headache Rep. 2019 Feb 21;23(2):10. doi: 10.1007/s11916-019-0750-8.
PubMed 30790138Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.
PubMed 30182753
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Link Between Human Cytomegalovirus Gene Expression and Glutamate Levels in Migraine :Relationship to the Vit D Deficiency
- ClinicalTrials.gov ID
- NCT06304948
- Acronym / sponsor ID
- Vitamin D and migraine
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 12 Mar 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.
- To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks
- To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.
- To correlate the serum level of glutamate with gene expression of in migraine
Detailed description
According to the report of global burden of disease (GBD) 2016, migraine headache has been established as the leading disability cause in the globe among under 50 years old [1]. It has been estimated that migraine affects about 11% of adults with a major impact on those aged between 25 to 55 years, which consequently lead to the high headache burden on individuals, communities, health care systems, and societies. Migraine is 2-3 times more common in women than in men. Migraine attacks are usually more prolonged, with higher intensity and more disability among females.
Current pharmacological treatments for migraine demonstrated limited efficacy in some patients and commonly lead to some adverse events such as weight reduction or weight gain, fatigue/sleepiness, sweating, night dreams, gastrointestinal upset and hypotension or reduced concentration. Novel therapeutic approaches of nutritional agents have become the promising strategies to alleviate symptoms of migraine. Vitamin D, one of the dietary agents, has revealed some potential in managing pain and migraine.
Cytomegalovirus (CMV) contamination is one of the clinically most critical irresistible complications of solid-organ transplantation. CMV disease, characterized as a critical rise within the titer of CMV-specific antibodies, happens in 44 % to 85% of kidney, heart, and liver transplant recipients - basically within the to begin with 3 months post transplantation, when immunosuppression is most intense. CMV malady shows in transplant beneficiaries essentially within the organ transplanted with the chance of successive dispersal and disability of other organs such as the central-nervous system, eye, and urogenital- or gastrointestinal tract. Additionally, dynamic CMV disease could be a noteworthy autonomous indicator of intense unite dismissal and event of artful contaminations.
Join brokenness and dismissal are related with vitamin D (VD) lack. In patients with end-stage organ disappointment anticipating transplant, VD lacking and lack are greatly common. Inadequately levels of vitamin D metabolites (25-hydroxyvitamin D [25(OH)D3] and 1,25-hydroxyvitamin D [1a,25_ Dihydroxyvitamin D3] have been detailed for patients with terminal congestive heart disappointment. pneumonic infection, liver disappointment [5], and incessant kidney illness.
in the past few years, there has been increasing interest in the complex interplay between vitamin D and infectious pathogens 7 Vitamin D supplementation is beneficial for patients with HIV, hepatitis C virus, Chlamydia spp. or mycobacterial infection. A significant reduction in the risk of CMV infection and disease by vitamin D supplementation would be highly attractive because of a high therapeutic index of vitamin D, the ease of application (oral solutions), and added benefits such as improved musculoskeletal health. Contrary to expectation, we found that CMV infection interferes with the vitamin D system of mammalian cells.
CMV infection downregulated vitamin D receptor expression and this downregulation was specific for CMV and was not observed for other, common human viruses. This observation may have far-reaching virological, immunological, and clinical implication
The aim of the present study was to assess a possible effect of migraine in patients with CMV infection on vit D levels and Glutamate levels to combine existing knowledge about the role of glutamate in migraine pathogenesis along with information on nutrients that are protective against glutamate excitotoxicity, and then end with a proposed dietary treatment for migraine management.
There is an obvious gap between our understanding of migraines and the dietary strategies which have been administered so far, since dietary nutrients are often studied separately, and no specific diet for migraine has been developed. However, the beneficial effects of the low glutamate diet on widespread chronic pain disorders appear to have overlapping mechanistic effects, and additionally is some preliminary evidence supporting an effect on migraine. Thus, further research on this dietary strategy in migraine is warranted
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria. And The age of the selected patients ranged between 15 and 55 years of both sexes
Key inclusion criteria (3 listed)
- Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria.
- The age of the selected patients ranged between 15 and 55 years of both sexes
- Able to give informed consent.
Key exclusion criteria (4 listed)
- b. Exclusion criteria:
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
The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency
Time frame: Baseline
Relation between CMV infection and glutamate level in patients with migraine in relation to vitamin D level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 29468450Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018 Feb 21;19(1):17. doi: 10.1186/s10194-018-0846-2. No abstract available.
- Background: PubMed 17803749Steininger C. Clinical relevance of cytomegalovirus infection in patients with disorders of the immune system. Clin Microbiol Infect. 2007 Oct;13(10):953-63. doi: 10.1111/j.1469-0691.2007.01781.x.
- Background: PubMed 16858268Hartmann A, Sagedal S, Hjelmesaeth J. The natural course of cytomegalovirus infection and disease in renal transplant recipients. Transplantation. 2006 Jul 27;82(2 Suppl):S15-7. doi: 10.1097/01.tp.0000230460.42558.b0.
- Background: PubMed 11310351Monegal A, Navasa M, Guanabens N, Peris P, Pons F, Martinez de Osaba MJ, Rimola A, Rodes J, Munoz-Gomez J. Bone mass and mineral metabolism in liver transplant patients treated with FK506 or cyclosporine A. Calcif Tissue Int. 2001 Feb;68(2):83-6. doi: 10.1007/BF02678145.
- Background: PubMed 32899880Latic N, Erben RG. Vitamin D and Cardiovascular Disease, with Emphasis on Hypertension, Atherosclerosis, and Heart Failure. Int J Mol Sci. 2020 Sep 4;21(18):6483. doi: 10.3390/ijms21186483.
- Background: PubMed 31584143Gallo D, Mortara L, Gariboldi MB, Cattaneo SAM, Rosetti S, Gentile L, Noonan DM, Premoli P, Cusini C, Tanda ML, Bartalena L, Piantanida E. Immunomodulatory effect of vitamin D and its potential role in the prevention and treatment of thyroid autoimmunity: a narrative review. J Endocrinol Invest. 2020 Apr;43(4):413-429. doi: 10.1007/s40618-019-01123-5. Epub 2019 Oct 4.
- Background: PubMed 25334038Kearns MD, Alvarez JA, Seidel N, Tangpricha V. Impact of vitamin D on infectious disease. Am J Med Sci. 2015 Mar;349(3):245-62. doi: 10.1097/MAJ.0000000000000360.
- Background: PubMed 30790138Wells RE, Beuthin J, Granetzke L. Complementary and Integrative Medicine for Episodic Migraine: an Update of Evidence from the Last 3 Years. Curr Pain Headache Rep. 2019 Feb 21;23(2):10. doi: 10.1007/s11916-019-0750-8.
- Background: PubMed 30182753Gazerani P, Fuglsang R, Pedersen JG, Sorensen J, Kjeldsen JL, Yassin H, Nedergaard BS. A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D3 supplementation in adult patients with migraine. Curr Med Res Opin. 2019 Apr;35(4):715-723. doi: 10.1080/03007995.2018.1519503. Epub 2018 Sep 28.
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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.
Essam S Darweish study director
Assuit u
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Omar (01006037604, ao5520904@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304948, which also lists 9 linked publications.
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 26 Mar 2024.