Clinical trial without control group, with parallel groups, single-blind, randomized, 82 patients
Settings and conduct
Location: Hazrat Rasoul Clinic, Shahrekord University of Medical Sciences, Method: 82 patients who met the inclusion criteria and did not meet the exclusion criteria were admitted to the study with consent and were randomly divided into two groups. One group received 250 mg of vitamin C daily for 2 months and the other group received magnesium oxide. The MSQ and Beck Depression Inventory are filled out by patients at the beginning and end of two months. Patients in both groups do not know which medication they are taking.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Their age is between 18 and 60 years.
2. According to ICHD-3 International Community Headache criteria, the diagnosis of migraine should be made by a neurologist at least one year in advance.
3. Diagnosis of moderate to severe migraine
Exclusion criteria
1. Fever or evidence of infection
2. Simultaneous infection with other headaches
3. A history of major depression
4. Daily use of painkillers
5. Pregnancy or pregnancy intention
6. Having chronic diseases
Intervention groups
Group one: 250 mg magnesium oxide tablets once daily orally for 8 weeks
Group 2: Vitamin C supplement tablets of 250 mg once daily orally for 8 weeks
Main outcome variables
The effect of migraine headaches on daily activities based on the MSQ questionnaire
Depression score based on Beck Depression Inventory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049787N1
Registration date:2021-01-16, 1399/10/27
Registration timing:prospective
Last update:2021-01-16, 1399/10/27
Update count:1
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Samira Sourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3336 4072
Email address
samira.sooraniii95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Magnesium Oxide and Vitamin C Supplementation in Prevention of Migraine Headaches
Public title
Magnesium Oxide and Vitamin C in Migraine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
According to ICHD-3 standards, the diagnosis of migraine should be made by a neurologist and they should be diagnosed with migraine at least one year before the visit
Diagnosis of moderate to severe migraine (which is the number of headache attacks 2-15 times a month or attacks with less intensity and duration that cause the person to be unable to perform daily tasks
Exclusion criteria:
Fever or evidence of infection
Simultaneous onset of other headaches such as tension headaches, sinusitis, or substance abuse headaches
People with active peptic ulcer and severe gastrointestinal disorders, especially chronic diarrhea
History of kidney failure
History of diabetes
history of major depression
History of asthma and heart disease (conduction block and heart failure)
Daily use of painkillers
Pregnancy or pregnancy intent
Having chronic diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
One-way blind blinding: Participants' informed consent is taken from the study before starting the study. Participants are divided into two groups according to the random number table method and do not know the type of drug used. Drugs are distributed in similar forms among patients
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients diagnosed with migraine who meet the inclusion criteria and do not meet the exclusion criteria are divided into two groups based on a random table of numbers. Then patients' written and informed consent to participate in the study is obtained. Take two vitamin C or magnesium oxide supplements that are packed in unspecified packages and are advised to take them daily for two months and to visit them monthly to complete the relevant questionnaire.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
No. 1, First Ave., sourani St., Manzarieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SKUMS.REC.1398.117
Health conditions studied
1
Description of health condition studied
Common Migraines
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
2
Description of health condition studied
Classic Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
The effect of migraine headaches on daily activities
Timepoint
At the beginning of the study and after eight weeks of medication
Method of measurement
MSQ questionnaire
2
Description
Depression score in Beck questionnaire
Timepoint
At the beginning of the study and after eight weeks of medication
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium oxide tablets 250 mg once daily orally for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin C 250 mg tablets once daily orally for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Clinic affiliated to Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Majid Jafari
Street address
Moulavi
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3226 4833
Email
jafarimd90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Majid Shirvani
Street address
Kashani Blvd., the headquarters of the university
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 9508
Email
src@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Samira Sourani
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 1, First Ave., Sourani St., Manzarieh
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Phone
+98 38 3336 4072
Email
samira.sooraniii95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Majid Jafari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Hajar Hospital., Parastar St
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
jafarimd90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Samira Soorani
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 1., First Ave., Sourani St., Manzarieh
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Phone
+98 38 3336 4072
Email
samira.sooraniii95@gmail.com
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