Evaluating the Effects of vitamin d and vitamin e on the Severity of Premenstrual Syndrome in the affected persons that go to medical-health centers of isfahan university of medical sciences
Object:The objective of the current study is to determine the
effect of vitamin D, vitaminE, and the placebo on the severity of PMS in the patients affected by the disease referred to the health centers of Isfahan University of Medical Sciences.
Design:The present study study is double blind randomized three groups clinical trial.
Setting and conduct: One hundred and fifty of PMS affected women were randomly selected and when the diagnosis was confirmed,assigned to each three group( vitamin D and vitamin E and placebo ).Medical intervention was carried out in two menstrual cycles and the results of pre- and post-test were compared.
Participants including major eligibility criteria: being 15-45 years old; having regular menstrual cycle; not being affected by depression or anxiety; not having an acute or chronic disease; not taking medicines or supplements; and not taking regular exercise.The exclusion criteria: pregnancy; willingness to use hormonal contraceptive methods or taking any hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment.
Intervention: Daily consumption of Vitamin D( Containing 200 mg of powdered vitamin D of MERK company, prepared by Isfahan Faculty of Pharmacy )or vitamin E(Containing 100 mg of powdered vitamin E of MERK company, prepared by Isfahan Faculty of Pharmacy) or placebo(Containing of Starch, prepared by Isfahan Faculty of Pharmacy) from the first day of the menstrual cycle until the first day of the next menstrual cycle for 2 cycles.
main outcome measures variables:The mean score of premenstrual syndrome
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401086854N2
Registration date:2014-05-19, 1393/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-19, 1393/02/29
Registrant information
Name
Elham Ebrahimi
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 22 1522 3903
Email address
ebrahimi_308@yahoo.com
Recruitment status
Recruitment complete
Funding source
Funding for this research was provided by the Research Council of Isfahan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of vitamin d and vitamin e on the Severity of Premenstrual Syndrome in the affected persons that go to medical-health centers of isfahan university of medical sciences
Public title
Effect of vitamin d and vitamin e on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being 15-45 years old; having regular menstrual cycle; not being affected by depression or anxiety; not having an acute or chronic disease; not taking medicines or supplements, and not taking regular exercise
The exclusion criteria: pregnancy; willingness to use hormonal contraceptive methods or taking any hormonal treatment; not taking the drug or not filling out the forms regularly; and unwillingness to continue the treatment.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethical comitee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib St,Azadi Squ, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2011-09-06, 1390/06/15
Ethics committee reference number
290147
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Mean score of syndrome
Timepoint
2 months before and 2 montha after
Method of measurement
Daily Rating Test
Secondary outcomes
1
Description
Side effect
Timepoint
2 months after intervention
Method of measurement
Questionaire
Intervention groups
1
Description
Daily consumption of Vitamin D( Containing 200 mg of powdered vitamin D of MERK company, prepared by Isfahan Faculty of Pharmacy )or vitamin E(Containing 100 mg of powdered vitamin E of MERK company, prepared by Isfahan Faculty of Pharmacy) from the first day of the menstrual cycle until the first day of the next menstrual cycle for 2 cycles.
Category
Treatment - Drugs
2
Description
Daily consumption of the placebo(Containing of Starch, prepared by Isfahan Faculty of Pharmacy) from the first day of the menstrual cycle until the first day of the next menstrual cycle for 2 cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Navabe Safavi and Ebne Sina health centers
Full name of responsible person
Nahid Fathizadeh
Street address
Navabe Safavi health center, Bozorgmehr squ, Isfahan,Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Nahid fathizadeh
Street address
Isfahan University of Medical Sciences, Hezarjarib St,Azadi Squ, Isfahan, Iran.
City
Isfahan
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,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
Shahrood University Of MedicalSciences.
Full name of responsible person
Elham Ebrahimi
Position
Phd candidated of reproductive health
Other areas of specialty/work
Street address
Shahrood University Of Medical Sciences,Hafte Teer Square, Shahroud, Iran
City
Shahrood
Postal code
Phone
+98 21 7631 0158
Fax
Email
Ebrahimi_308@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
Nahid Fathizadeh
Position
Msc
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjarib St,Azadi Squ, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 913 100 4312
Fax
Email
Ebrahimi_308@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University Of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Phd condidated of reproductive health
Other areas of specialty/work
Street address
Shahrood University Of Medical Sciences, Hafte Teer Square, Shahrood, Iran.
City
Shahrood
Postal code
Phone
+98 936 548 9806
Fax
Email
EBRAHIMI_308@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)