The aim of this study is to investigate the effect of selenium supplementation on clinical characteristics, oxidative stress, mental health and quality of life in migraine patients.
Design
Randomized, placebo-controlled, phase 3 on 72 patients. A four-block randomization method will be used.
Settings and conduct
This study will be conducted on migraine patients referring to the neurology clinic of Al-Zahra Hospital in Isfahan city. At the beginning and end of the 12th week, anthropometric indices and blood pressure will be evaluated, and venous blood samples will be taken from the patients. Blinding will be done for patients and researchers.
Participants/Inclusion and exclusion criteria
Inclusion criteria including: migraine diagnosis by a neurologist based on international classification of headache-3, age of 18 to 65 years, having at least two migraine attacks per month, and body mass index of 18.5-30.
Exclusion criteria including: pregnancy and lactation, taking antioxidant supplements in the last 3 months, and having a medical history of infectious disorders, cardiovascular diseases, diabetes, liver and kidney diseases, other neurological diseases such as tension headache, epilepsy, Parkinson's and multiple sclerosis.
Intervention groups
The patients in the intervention group will receive a 200 microgram selenium tablet (Health Burst) daily for 12 weeks. Control group patients will receive a placebo tablet containing starch and calcium phosphate (Faculty of Pharmacy, Isfahan University of Medical Sciences) daily for 12 weeks.
Main outcome variables
Migraine symptoms, patients' quality of life, mental health, oxidative stress status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N60
Registration date:2023-05-27, 1402/03/06
Registration timing:registered_while_recruiting
Last update:2023-05-27, 1402/03/06
Update count:1
Registration date
2023-05-27, 1402/03/06
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of selenium supplementation on oxidative stress factors and clinical signs in patients with migraine
Public title
The effect of selenium on migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine diagnosis based on International Classification of Headache Disorders-3
Age of 18 to 65 years
At least two migraine attacks per month
BMI of 18.5 to 30 kg/m2
Exclusion criteria:
Pregnancy or lactation
Taking antioxidant supplements 3 month before the intervention
Suffering from infectious disorders, cardiovascular diseases, diabetes, liver and kidney diseases, other neurological disorders including tension headache, epilepsy, Parkinson and multiple sclerosis .
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients will be done using a four-block randomization method. For this purpose, people were classified into 4 states based on the variables of gender (female, male) and age (<40, ≥40 years) and people with the same states were randomly assigned to intervention and placebo groups in a 1:1 ratio. Block randomization will be done using a list of random numbers generated by the website https://www.sealedenvelope.com/simple and by an independent researcher. Investigators and patients will remain blinded to allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind randomized controlled trial. The selenium supplement and placebo (identical in terms of color, smell, shape, and size) will be packaged in similar boxes, and the participants and the outcome assessor will not be informed of the contents of the packages until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.404
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Clinical characteristics of migraine (frequency, severity, and duration of migraine headaches, and headache impact-test-6)
Timepoint
At baseline and after 12 weeks
Method of measurement
Headache dairy and headache impact test-6 questionnaire
2
Description
Serum nitric oxide
Timepoint
At baseline and after 12 weeks
Method of measurement
Kiazist biochemical kit
3
Description
Oxidant indices (malondialdehyde, total antioxidant capacity, and total oxidative status)
Timepoint
At baseline and after 12 weeks
Method of measurement
Kiazist biochemical kit
4
Description
Mental health
Timepoint
At baseline and after 12 weeks
Method of measurement
DASS questionnaire
5
Description
Quality of life
Timepoint
At baseline and after 12 weeks
Method of measurement
Migraine patients-specific quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patients will receive for 12 weeks a tablet containing 200 microgram selenomethionine (Health Burst) daily.
Category
Treatment - Drugs
2
Description
Control group: The patients will receive for 12 weeks a placebo tablet containing starch and calcium phosphate (The School of Pharmacy, Isfahan University of Medical Sciences, Isfahan) daily.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of Al-Zahra Hospital
Full name of responsible person
Dr. Gholamreza Askari
Street address
Soffeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3222 2127
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Deputy of search & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezae Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Harib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available