Protocol summary

Summary
The aim of present study is to investigate the effects of vitamin D supplement on symptoms and inflammatory indices in patients with migraine. Inclusion criteria and exclusion criteria are confirmation of disease by neurologist and the use of antimigraine drugs, respectively. For this purpose, we enroll 90 patients with migraine . The participants will categorize to 2 groups ( interverntion and placebo group) to receive 50000 IU vitamin D or placebo/week for 10 weeks. Finally, at first and end of intervention, effect of vitamin D on migraine symptoms ( severity , frequency , average duration of migraine attacks ) and CRP will iinvestigate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012122911763N4
Registration date: 2013-01-17, 1391/10/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-01-17, 1391/10/28
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 Sciences
Expected recruitment start date
2013-03-19, 1391/12/29
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of vitamin D supplementation on symptoms and inflammatory indices in patients with migraine
Public title
Vitamin D and migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged 10-61 years; confirmation of migraine by neurologist; desire to participate in present study; do not use of corticosteroids,OCP,vitamin D, magnesium,calcium and riboflavin; do not take of antimigraine drugs; lack of tension headaches. Exclusion criteria: having diseases of liver , kidney and primary hyperparathyroidism; hypervitaminosis D
Age
From 10 years old to 61 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan univesity of medical sciences
Street address
Isfahan, Hezarjirib street
City
Isfahan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
391212

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified

Primary outcomes

1

Description
C-reactive protein (CRP)
Timepoint
First and end of intervention
Method of measurement
Laboratory analysis ( blood test)

2

Description
Migraine symptoms ( severity , frequency and average duration of migraine attacks)
Timepoint
first and end of intervention
Method of measurement
Questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:vitamin D, 50000 IU, every week 1 supplement, 10 weeks
Category
Treatment - Drugs

2

Description
Placebo group: placebo, every week 1 supplement, 10 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid hospital
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
Isfahan , hezar jirib street
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
Tayebeh Mottaghi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
Hezarjirib street
City
Isfahan
Postal code
Phone
+98 31 1792 2658
Fax
Email
tmottaghi@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
Hezarjirib street
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
Tayebeh Mottaghi
Position
MSc of Nutrition
Other areas of specialty/work
Street address
Isfahan, Hezarjirib street
City
Isfahan
Postal code
Phone
+98 31 1792 2658
Fax
Email
tmottaghi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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