In this study we examined the effect of magnesium on the severity and frequency of migraine headaches. this study is a clinical trial. In this study, patients were selected on the basis of moderate and severe type of migraine headache and no infection, fever and tension type headaches symptom and data were extracted from check list. The patients were divided randomly into two groups of 50. The first group in addition to the usual migraine medication, magnesium oxide pills was prescribed and vitamin E as a placebo was administered to the control group. Changes in serum magnesium levels and the severity and frequency of migraine headaches, one and three months after the start of the study were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091617945N2
Registration date:2014-12-24, 1393/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-24, 1393/10/03
Registrant information
Name
Ghasem Fattahzadeh Ardalani
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1552 2086
Email address
gh.fattahzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2013-09-29, 1392/07/07
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on Relation Between Serum Magnesium Level and Severity and Frequency of Attacks of Migraine Headache
Public title
Investigation on Relation Between Serum Magnesium Level and Severity and Frequens of Attacks of Migraine Headache
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years; Moderate to severe pain for 4-72 hours or more.
exclusion criteria: Fever or evidence of infection; Headaches; Pregnancy; Diabetes; Blood pressure; Ischemic heart disease and kidney disease.
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:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil, Daneshgah street, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
arums.rec.92.23
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Serum Magnesium levels
Timepoint
During the visit, a visit next month, the first two months
Method of measurement
laboratory
2
Description
frequency of migraine headaches
Timepoint
During the visit, a visit next month, the first two months
Method of measurement
standard check list
3
Description
severity of migraine headaches
Timepoint
During the visit, a visit next month, the first two months
Method of measurement
standard check list
Secondary outcomes
empty
Intervention groups
1
Description
Magnesium oxide tablets 250 mg orally every 12 hours.
Category
Treatment - Drugs
2
Description
Tablets of vitamin E, 100 mg every 12 hours, oral
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Alavi hospital
Full name of responsible person
Dr Ghasem Fattahzadeh
Street address
Alavi hospital, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ghasem Fattahzadeh Ardalani
Street address
Ardabil, Daneshgah street, Ardabil University of Medical Sciences
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Bahare javani
Position
General physisian
Other areas of specialty/work
Street address
Ardabil
City
Ardabil
Postal code
Phone
+98 457715351
Fax
Email
bahare_javani2007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Ghasem Fattahzadeh Ardalani
Position
Assistant Professor
Other areas of specialty/work
Street address
Ardabil, Daneshgah street, Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 457715351
Fax
Email
gh.fattahzadeh@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Bahare javani
Position
Gerenal Physician
Other areas of specialty/work
Street address
City
Ardabil
Postal code
Phone
+98 45 3371 5351
Fax
Email
bahare_javani2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)