The effect of folic acid and pyridoxine supplementation on symptoms, severity of headache and inflammatory markers in patients with Migraine with aura (MA)
The aim of present study is to investigate the effects of pyridoxine and folic acid supplementation on symptoms and inflammatory indices in patients with migraine with aura (MA) for 3 month. Inclusion criteria and exclusion criteria are confirmation of MA by neurologist and the use of pyridoxine and folic acid supplement, respectively. For this purpose, we enroll 120 patients with MA. The participants will categorize to 3 intervention groups and 1 placebo group. Patients in group 1, will receive 80 mg/d pyridoxine and 5 mg/d folic acid. Group 2 and 3 receive 80 mg/d pyridoxine and 5 mg/d folic acid, respectively. Group 4 consider as placebo group. Finally, at first and end of intervention, effect of pyridoxine and folic acid on migraine symptoms ( severity , frequency , average duration of migraine attacks ) and CRP will investigate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013060411763N9
Registration date:2014-04-12, 1393/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
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
Isfahan University of Medical Science, Isfahan, Iran
Expected recruitment start date
2013-02-01, 1391/11/13
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of folic acid and pyridoxine supplementation on symptoms, severity of headache and inflammatory markers in patients with Migraine with aura (MA)
Public title
The effect of folic acid and pyridoxine supplementation on symptoms of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Patients suffered from migraine in a long time with current diagnosis of MA and a one-year history of severe; recurrent attacks(1 to 8 attacks per month) were selected; The patients with chronic heart disease; previous stroke incidence; chronic renal failure and also with history of taking vitamin B supplements were excluded from the study.
Age
From 15 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Isfahan University of Medical Sciences, Isfahan, Iran, Hezargarib street
City
Isfahan
Postal code
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
392363
Health conditions studied
1
Description of health condition studied
Migraine with aura
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura [classical migraine]
Primary outcomes
1
Description
Severity of migraine attacks
Timepoint
First and end of intervention (3 month)
Method of measurement
VAS scale
2
Description
Frequency of migraine attacks
Timepoint
First and end of intervention (3 month)
Method of measurement
Questionnaire
3
Description
Duration of migraine attacks
Timepoint
First and end of intervention (3 month)
Method of measurement
Questionnaire
4
Description
Homocysteine level
Timepoint
First and end of intervention (3 month)
Method of measurement
Laboratory analysis ( blood test)
5
Description
Crp level
Timepoint
First and end of intervention (3 month)
Method of measurement
Laboratory analysis ( blood test)
Secondary outcomes
empty
Intervention groups
1
Description
Patients in group 3 received 80 mg/d pyridoxine for 12 weeks.
Category
Treatment - Drugs
2
Description
Patients in group 4 considered as control, received placebo (lactose) for 12 weeks.
Category
Placebo
3
Description
patients in group 1 received 5 mg/d folic acid and 80 mg/d pyridoxine for 12 weeks
Category
Treatment - Drugs
4
Description
Patients in group 2 received 5 mg/d folic acid for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Isfahan, Ostandari street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Isfahan University of Medical Sciences
Full name of responsible person
Dr Peyman Adibi
Street address
Iran, Isfahan, Hezargarib street, Esfahan university of medical sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
Iran, Isfahan, Hezargarib street, Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1792 2658
Fax
Email
omidsadeghi69@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
MD & PhD (Nutritionist)
Other areas of specialty/work
Street address
Iran, Isfahan, Hezargarib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2110
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Omid Sadeghi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
Isfahan, Hezarjirib street
City
Isfahan
Postal code
Phone
00
Fax
Email
omidsadeghi69@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)