NCT06304948

Brief Summary

  1. 1.To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks
  2. 2.To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.
  3. 3.To correlate the serum level of glutamate with gene expression of in migraine

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 5, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 29468450BACKGROUND
  • Steininger 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.

    PMID: 17803749BACKGROUND
  • Hartmann 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.

    PMID: 16858268BACKGROUND
  • Monegal 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.

    PMID: 11310351BACKGROUND
  • Latic 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.

    PMID: 32899880BACKGROUND
  • Gallo 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.

    PMID: 31584143BACKGROUND
  • Kearns 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.

    PMID: 25334038BACKGROUND
  • Wells 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.

    PMID: 30790138BACKGROUND
  • Gazerani 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.

    PMID: 30182753BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Essam S Darweish

    Assuit u

    STUDY DIRECTOR

Central Study Contacts

Essam S Darweish, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor resident

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

May 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

March 26, 2024

Record last verified: 2024-03