Migraine is one of the most common paroxysmal disorders which can disable patients. In this study we are going to compare the effect of oral magnesium versus placebo on migraine headache in pregnancy period. 64 pregnant women with diagnosis of migraine referred to neurology clinic will be included in this study and randomly will be divided into two groups. 32 patients receive oral magnesium and the other 32 cases receive placebo. We will visit them every 4 weeks up to 12 weeks. We will test serum magnesium level from all patients before and at the end of first and second months after treatment initiation. Severity, duration and frequency of headache, amount of analgesic use and side effects of the drugs in each group will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062128559N1
Registration date:2016-11-14, 1395/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-14, 1395/08/24
Registrant information
Name
Nasrin Moradian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3836 2562
Email address
n_moradian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral magnesium and placebo in migraine prophylaxis in pregnancy period
Public title
A comparative study of the effects of oral magnesium versus placebo in migraine prophylaxis in pregnancy period
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of migraine according to definition of International Headache Society by a neurologist; at least one year has passed form the time of migraine onset; moderate to severe headache; more than 2 headache attacks per month.
Exclusion criteria: Having tension headaches or other non-migraine headaches; overuse of analgesic medications (more than 15 days a month); use of any migraine prophylactic drugs; history of previous or recently infection; history of chronic diseases (diabetes, hypertension, cardiac, vascular, renal and hepatic); use of mineral supplements; substance and alcohol abuse.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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
Kermanshah University of Medical Sciences and Health Servises Ethical Comitte
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti boulvered, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
KUMS.REC.1394.478
Health conditions studied
1
Description of health condition studied
Common Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura (common migraine)
2
Description of health condition studied
Classical Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura (classical migraine)
Primary outcomes
1
Description
Severity of headache
Timepoint
In each migraine attack
Method of measurement
Patient will record the headache severity in daily notes as VAS, MIDAS,HITS-6& physician registers them every 4 weeks
2
Description
Duration of migraine attack
Timepoint
In each migraine attack
Method of measurement
Patient records the hours of headache in each attack , physician registers them every 4 weeks
3
Description
Headache frequency
Timepoint
In each migraine attack
Method of measurement
According to patient records
4
Description
Analgesic use
Timepoint
Every 4 week
Method of measurement
According to patient records
Secondary outcomes
1
Description
Clinical side effects
Timepoint
Every 4 weeks
Method of measurement
According to patients notes
Intervention groups
1
Description
Magnesium Oxide, 250 mg tablets, 2 times a day (Minoo Company), for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo tablets identical to magnesium tablets in shape and color, 2 times a day, for 12 weeks. Placebo tablets are made in pharmacology faculty of Kermanshah University of Medical Sciences.