Protocol summary
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Study aim
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prevention
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Design
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Clinical trial without control group, with parallel groups, single-blind, randomized, 82 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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The effect of migraine headaches on daily activities based on the MSQ questionnaire
Depression score based on Beck Depression Inventory
General information
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Reason for update
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Regarding the method of blinding the study, after consulting again with the statistical consultant of the project to improve the scientific level of the study, it was decided that the type of randomization method in this two-way trial is blind so that the researcher and patients decide which drug is among the two drugs introduced in The schemes used are uninformed but the clinical caregiver divides and distributes the drugs in similar packages..
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201221049787N1
Registration date:
2021-01-16, 1399/10/27
Registration timing:
prospective
Last update:
2021-01-20, 1399/11/01
Update count:
1
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Registration date
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2021-01-16, 1399/10/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the Effectiveness of Magnesium Oxide and Vitamin C Supplementation in Prevention of Migraine Headaches
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Public title
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Magnesium Oxide and Vitamin C in Migraine
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
82
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization by random number table method: After filling the informed consent of the study participants, patients will be divided into two groups by random number table method and will receive and consume one of the two drugs studied in the plan.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double blind blindness: The clinical researcher and the patients participating in the project are not aware of the type of drug used and only the clinical caregiver, knowing the type of drug, distributes it in similar envelopes. It should be noted that the drugs are similar in dose, color and shape. Also, the envelopes are nameless and recognizable only to the clinical caregiver.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-28, 1398/05/06
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Ethics committee reference number
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IR.SKUMS.REC.1398.117
Health conditions studied
1
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Description of health condition studied
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Common Migraines
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ICD-10 code
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G43.0
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ICD-10 code description
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Migraine without aura
2
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Description of health condition studied
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Classic Migraine
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ICD-10 code
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G43.1
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ICD-10 code description
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Migraine with aura
Primary outcomes
1
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Description
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The effect of migraine headaches on daily activities
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Timepoint
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At the beginning of the study and after eight weeks of medication
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Method of measurement
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MSQ questionnaire
2
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Description
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Depression score in Beck questionnaire
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Timepoint
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At the beginning of the study and after eight weeks of medication
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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Intervention group: Magnesium oxide tablets 250 mg once daily orally for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Vitamin C 250 mg tablets once daily orally for 8 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahre-kord University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available