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The effect of Iron therapy on severity and frequency of migraine headaches of 15-45 year old patients with iron deficiency

Protocol summary

Summary
Objectives: This study is carried out to evaluate the effect of iron therapy on severity and duration of headache attacks in migraineous with iron deficiency. Designed:In this semi-experimental study, 90 women aged 15-45 year with migraine in Shahrekords Ayatallah Kashany clinic ,will be assigned , into three groups (N=30 each) include , A : with negative balance of iron , B : with iron deficiency anemia , C: with normal level of iron. Interventions: All 3 groups will be prescribed 400mg valproate Na daily for 45 days , tha second period of the study all patients will be recieved exrera iron sulfate (3 tablets) . It is allowed to give the patients 25mg Indometasine capsule if it is necessary. Data collection :Patients will be followed up every 15 days by either direct visit or phone . At the end of each period , in additon to collecting related Smear questionnaire , the samples of peripheral blood and iron supply will be collected. Exclusion criteria :Pregnancy , breast feeding ,using psychiatric drugs , oral con teraceptive pill or other sexual hormons , having systemic disease such as haypertnsion and asthma . Main outcome mesures: Frequency and severity of headache attacks will be recorded and compared in three groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107117004N1
Registration date: 2011-10-29, 1390/08/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-10-29, 1390/08/07
Registrant information
Name
Shamsali Khosravi
Name of organization / entity
Shahrekord Medical University
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 4754
Email address
khosravishamsali@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Sciences
Expected recruitment start date
2011-08-10, 1390/05/19
Expected recruitment end date
2012-02-27, 1390/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Iron therapy on severity and frequency of migraine headaches of 15-45 year old patients with iron deficiency
Public title
Iron therapy in migraine headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: ٌFemale Patients having migraine; age between 15 to 45 years; the first group with negative balance of iron; the second group with iron deficiency; third group with normal level of iron. (Patients with the following characters will be considered as iron deficiency (MCHC<30g/d,MCV<80fl,Tibc>360µg/dl, MCH<27pg/d,Hb<10g/dl, HCT). Patients with feritin less than 20 microgram in liter will be considered as negative balance of iron.) Exclusion criteria: Pregnancy, lactation, using psychiatric, OTC or other sexual hormones, having systemic illness such as hypertension, asthma.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shahrekord University of Medical Sciences
Street address
Kashani Street
City
SHahrekord
Postal code
8136893669
Approval date
2008-03-05, 1386/12/15
Ethics committee reference number
5-12-86

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
frequency of headache attacks
Timepoint
three periods of 15 days
Method of measurement
questionnaire

2

Description
severity of headache attacks
Timepoint
three periods of 15 days
Method of measurement
questionnaire

Secondary outcomes

1

Description
Ferritin
Timepoint
At the beginning and at the end of the study
Method of measurement
Laboratory methods

2

Description
blood iron
Timepoint
At the beginning and at the end of the study
Method of measurement
laboratory methods

Intervention groups

1

Description
in negative balance of iron group will receive 400 mg/day valproate Na in all periods (45 days each period) and iron sulfate (50mg/day) in second period of the study.
Category
Treatment - Drugs

2

Description
in iron deficiency anemia group will receive 400 mg/day valproate Na in all periods (45 days each period) and iron sulfate (50mg/day) in second period of the study.
Category
Treatment - Drugs

3

Description
in normal level of iron group will receive 400 mg/day valproate Na in all periods (45 days each period) and iron sulfate (50mg/day) in second period of the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariaty street , Ayatollah Kashani Hospital
Full name of responsible person
Mahmoud Mirzaei M.D
Street address
10 Shariaty street, Shahrekord, Iran
City
SHahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Mobasheri
Street address
Vice chancellor for research, Shahrekord University of Medical Sciences, Kashani Bld
City
Shahrekord
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, Shahrekord 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
SHahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Rafieian
Position
Head of Medical Plants Research Center, professor of pharmacology
Other areas of specialty/work
Street address
10 Rahmatieh, Medical Plants Research Center, Shahrekord, Iran
City
SHahrekord
Postal code
Phone
+98 38 1334 6692
Fax
+98 38 1334 6692
Email
rafieian@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Mirzaei
Position
Asossiate Professor of Nerology depaetment
Other areas of specialty/work
Street address
10 Rahmatieh, Medical Plants Research Center, Shahrekord, Iran
City
shahrekord
Postal code
Phone
+98 38 1333 4749
Fax
Email
Ghmirzaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mahmoud Rafieian
Position
Professor of pharmacology
Other areas of specialty/work
Street address
10 Rahmatieh, Medical Plants Research Center, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1334 6692
Fax
Email
rafieian@yahoo
Web page address

Sharing plan

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