Effect of zinc supplementation on symptoms of headache in patients with migraine
Design
Design: we will enroll 80 eligible patients with migraine aged 20- 60 years that will randomly be assigned into treatment and placebo groups.
Settings and conduct
Setting and conduct: The present study is a double blind method and the care provider, investigator, outcome assessor, data analyzer will not be aware of assigned interventions. Samples are patients with migraine that will be recruited from Imam Mousa Sadr Clinic and Ali Asghar Clinic. The participants will randomly assigned into treatment and placebo groups to receive Zinc supplementation or placebo tablets for 8 weeks.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: aged 20-60 years; confirmation of migraine by neurologist; desire to participate in present study; do not use of oral contraceptive pill and lack of tension headaches.
Major exclusion criteria: having chronic medical diseases; use of supplements containing (Zn, vitamin E, vitamin C, Selenium and Beta-carotene)
Intervention groups
Intervention group will receive supplementation of zinc sulfate (220 mg per day including 50 mg of elemental zinc, Alhavi Company) for 8- weeks and subjects in the other group will receive placebo (made at the School of Pharmacy, Isfahan University of Medical Sciences) during 8 weeks.
Main outcome variables
outcome measures variables: Migraine symptoms ( severity , frequency and average duration of migraine attacks).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N23
Registration date:2018-01-16, 1396/10/26
Registration timing:retrospective
Last update:2018-01-16, 1396/10/26
Update count:0
Registration date
2018-01-16, 1396/10/26
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
University of Medical Sciences is responsible for all costs
Expected recruitment start date
2016-02-01, 1394/11/12
Expected recruitment end date
2016-04-01, 1395/01/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of zinc supplementation on symptoms among patients with migraine in comparison with placebo
Public title
Effect of Zinc supplementation on symptoms of migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged 20-60 years;
confirmation of migraine by neurologist;
desire to participate in present study;
do not use of oral contraceptive pill,
lack of tension headaches.
Exclusion criteria:
having chronic medical diseases;
use of supplements containing Zn, vitamin E, vitamin C,
Selenium and Beta-carotene
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In present study, simple randomization method will be used. The randomization unit is individually and we will use the random number table method for random sequences. A random numbered table is a collection of numbers that are without a specific pattern, completely random and as table. The next step is allocation concealment and will use sequentially numbered, sealed, opaque envelopes. Then, based on the sample size, number of envelopes with aluminum surface are provided and each random sequence created on a card and the cards are inserted into the envelopes, respectively. At the time of registration for the participants, according to eligible participants, one of the envelopes is opened and the allocated group for participants is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplementation zinc and placebo will be packed in capsules that are identical in outward
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.MUI.REC.1394.3.963
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
Migraine symptoms ( severity, frequency and average duration of migraine attacks)
Timepoint
At first and end of intervention
Method of measurement
Questionaire
2
Description
C-reactive protein (CRP)
Timepoint
At first and end of intervention
Method of measurement
Laboratory analysis ( blood test)
Secondary outcomes
1
Description
Migraine Disability Assessment
Timepoint
At first and end of intervention
Method of measurement
Questionaire
Intervention groups
1
Description
Intervention group: Supplementation of zinc sulfate (220 mg including 50 mg of elemental zinc, Alhavi Company), every day 1 supplement, 8 weeks
Category
Treatment - Drugs
2
Description
control group: placebo (made at the School of Pharmacy, Isfahan University of Medical Sciences ), every day 1 supplement, 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliasghar hospital clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
2
Recruitment center
Name of recruitment center
Imam Mousa Sadr Clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Medical Sciences of Esfahan
Full name of responsible person
Dr Amir mansour alavi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Medical Sciences of Esfahan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hedieh Ahmadi
Position
MSc of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
hedieh_ahmadi85@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Askari
Position
PhD of Nutrition sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31337923171
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hedieh Ahmadi
Position
MSc of Nutrition
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
Email
hedieh_ahmadi85@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available