Migraine is common all over the world.In this study we assessed relationship between serum vitamin D level with migraine headache frequency and severity in migraine patients referred to Neurology Clinic of Rasoul Akram Hospital, Tehran, Iran, 2013. Totally 70 migraine patients according to neurologist diagnosis were selected.Those with underlying diseases such as hyper para thyroidisim, renal stone, renal impairment were excluded. Serum vitamin D level were measured. patients are divided into 2 equal groups. First group is given 1000 IU vitamin D3 daily for 11 weeks. Second group is given the same amount of placebo. 1.5 month later, serum vitamin D level is rechecked in order to preventing hyper vitaminosys of vitamin D.After 3 months all patients are asked to come to the Clinic and their information regarding frequency and severity of headache will be recorded for further comparison and conclusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013101415020N1
Registration date:2013-12-14, 1392/09/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-14, 1392/09/23
Registrant information
Name
Seyyedeh Maryam Hashemi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 8996
Email address
info@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University Of Medical Sciences
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D3 on frequency and severity of migraine headache in patients referred to neurology clinic of Rasool Akram Hospital in Tehran,1392
Public title
migraine headache attacks prevention by prescribing vitamin D
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: patients with a diagnosis of migraine headache with no history of underlying diseases such as hyperparathyroidism; cardiac diseases; renal impairment; renal stone; normal or lower serum vitamin D level; no drug history of those interacting with serum vitamin D level
exclusion criteria:increasing in serum vitamin D levels over than normal.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3519899951
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
92/16/6919
Health conditions studied
1
Description of health condition studied
migraine headaches
ICD-10 code
G43
ICD-10 code description
migraine
Primary outcomes
1
Description
frequency of migraine headaches
Timepoint
before intervention, 3months after the initial intervention
Method of measurement
standard questionnarie
2
Description
severity of migraine headaches
Timepoint
before intervention, 3months after initial intervention
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
increasing in serum vitamin D level more than normal level
Timepoint
before intervention,1.5 month after the initial intervention
Method of measurement
serum vitamin D level in blood sample
Intervention groups
1
Description
each patient is given 1000 IU of oral vitamin D3 daily for 11 weeks.
Category
Treatment - Drugs
2
Description
each patient is given 1000 IU of oral placebo daily for 11 weeks