UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058501 |
|---|---|
| Receipt number | R000066885 |
| Scientific Title | Prevalence, diagnosis, and treatment of migraine due to iron deficiency |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/07/17 15:20:26 |
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Basic information
Public title
Prevalence, diagnosis, and treatment of migraine due to iron deficiency
Acronym
Prevalence, diagnosis, and treatment of migraine due to iron deficiency
Scientific Title
Prevalence, diagnosis, and treatment of migraine due to iron deficiency
Scientific Title:Acronym
Prevalence, diagnosis, and treatment of migraine due to iron deficiency
Region
| Japan |
Condition
Condition
Migraine
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Iron deficiency has been attracting attention as a possible modifying factor involved in the pathology of migraine, and its comorbidity has been reported, especially in young women. Neuroimaging studies have suggested abnormalities in intracerebral iron deposition in migraine patients, and abnormal iron metabolism may affect migraine susceptibility and treatment response. However, accurate clinical assessment of iron deficiency is difficult because the diagnostic criteria for iron deficiency are not unified and the prevalence varies greatly depending on the evaluation method. In recent years, the introduction of CGRP-targeted drugs has made great progress in preventive treatment of migraine, but there are still cases in which sufficient efficacy is not achieved. Iron deficiency is common and can be improved by appropriate intervention, so it is clinically important as a potential intervention target that can improve treatment response. In this study, we will clarify the prevalence of iron deficiency in migraine patients based on standard diagnostic criteria and examine whether iron supplementation therapy can complement the preventive treatment effect. We will also evaluate the usefulness of iron supplementation monotherapy in pregnant and lactating patients and consider the importance of iron supplementation therapy in migraine treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of iron deficiency in migraine patients (assessed based on hemoglobin [Hb], serum iron [Fe], total iron-binding capacity [TIBC], transferrin saturation [TSAT: calculated as Fe/TIBC], and serum ferritin)
Key secondary outcomes
Clinical usefulness of iron supplementation therapy (improvement in MHD, HIT-6, and MIBS-4), and efficacy of iron monotherapy during pregnancy and lactation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | years-old | <= |
Age-upper limit
| 81 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited a participating facility for outpatient treatment with migraine between April 1, 2022 and May 22, 2025.
Key exclusion criteria
Patients with vertebral artery dissection, brain tumor, or other vascular disorders were excluded. Patients with insufficient data on iron-related parameters were excluded.
Target sample size
631
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare, Narita Hospital
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita Chiba
TEL
0476355600
esuehiro@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Suehiro |
Organization
International University of Health and Welfare Narita Hospital
Division name
Neurosurgery
Zip code
286-8520
Address
852 Hatakeda Narita Chiba
TEL
0476355600
Homepage URL
esuehiro@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Narita Hospital
Address
852 Hatakeda Narita Chiba
Tel
0476355600
esuehiro@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint: To determine the prevalence of iron deficiency in migraine patients, and to evaluate diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated. Iron deficiency was classified into the following four groups based on five indices: Hb, Fe, TIBC, TSAT, and ferritin. Normal iron status: all indices within the reference range. Functional iron deficiency: TSAT<20%, Hb and ferritin normal. Storage iron deficiency: low ferritin (women < 30 ng/mL, men < 50 ng/mL), Hb normal. Iron deficiency anemia (IDA): Hb below gender-specific norm (women<12.0 g/dL, men<13.0 g/dL) and accompanied by Fe<50 ug/dL, TIBC>400 ug/dL, TSAT<20%, or low ferritin. Comparison between two groups: t-test or Mann-Whitney U test was used for continuous variables, and chi-square test or Fisher's exact test was used for categorical variables. The significance level was set at p<0.05 (two-sided test).
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066885
