The Effect of Vit D and Vit E Gelatin Capsuls on Severity and Duration of Dysmennorrhea in Women referred to Shahid Motahari gynecology clinics in Urmia
Design
A randomized, double-blind clinical trial with a control group and a parallel group design of 100 patients was conducted between 2016-2017
Settings and conduct
In this double-blinded randomized clinical triaIn 100 eligible women with dysmenorrhea who attended Kowsar gynecological clinic of Shahid Mottahari Hospital of Urmia University of Medical Sciences, during 2016-2017 categorized into four groups that received capsules containing a placebo (n = 25), 420 mg Vitamin D (n = 25), 400 mg Vitamin E (n = 25), and 420 mg Vitamin D + 400 mg Vitamin E (n = 25) every 24 hours for two consecutive months with starting at the beginning of the menstrual period
Participants/Inclusion and exclusion criteria
Patients were whom that has a history of primary dysmenorrhea over three menstrual cycles for at least one day per month they were studied inside . Any subjects with a history of chronic and systemic problems such as gynecological disease and significant medical history or active disease were excluded.
Inclusion criteria were: being within the age group of 18-50 years; were no present history of gynecologic or psychological diseases, no urogenital disorders; no usage of herbal remedies, coagulation disorders or; regular menstrual cycles and no history of pelvic or abdominal surgery
Intervention groups
100 eligible women with dysmenorrhea categorized into four groups with 25 members.
After that, the samples were determined randomly assigned to vitamin E group or Vitamin D group, vitamin E + Vitamin D group and placebo group (25 participants in each group).
Main outcome variables
Time of onset of pain, duration of pain, severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026962N4
Registration date:2020-08-03, 1399/05/13
Registration timing:retrospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Tahereh Behroozi Lak
Name of organization / entity
Educational and Treatment Kowsar Center
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
behroozilak.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2017-01-05, 1395/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D and Vitamin E on Ameliorating Intensity and Duration of Dysmenorrhea in Iranian Women
Public title
Investigating the effect of vitamin D and vitamin E on Intensity and Duration of Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being within the age group of 18-50 years
Were no present history of gynecologic or psychological diseases, no urogenital disorders
No usage of herbal remedies
No history of coagulation disordersand
No history of iregular menstrual cycles
No history of pelvic or abdominal surgery
Exclusion criteria:
Individuals with a history of specific illness
Individuals with a history of forced drug use
Individuals with a history of symptoms such as burning, itching, discharge,
Individuals with a history of irregular periods
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized clinical trial, samples will be randomly selected and randomly selected based on a table of random numbers into 4 equal groups of 25, including 3 experimental groups and a control group. In this study, assignment sequencing and preparation Supplemental and placebo packages in similar packages will be done by a person not involved in sampling and data collection. He did not know about the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is an RCT (randomized clinical trial) and will be performed on adouble-blind side . In this way, neither the subjects nor the person who will analyze the data will know which drug group and which treatment group received the treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciens
Street address
Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia university of medical sciens
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.UMSU.Rec.1394.63
Health conditions studied
1
Description of health condition studied
The Effect of Vitamin D and Vitamin E on Ameliorating Intensity and Duration of Dysmenorrhea
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain duration
Timepoint
Once before giving the desired treatments and placebo and once after a month and finally two months of continuous use of drugs and placebo
Method of measurement
Cox Menstrual Symptom Scale Questionnaires
2
Description
Severity of the pain
Timepoint
Once before giving the desired treatments and placebo and once after a month and finally two months of continuous use of drug and placebo
Method of measurement
Visual Analog Scale(VAS) Questionnaires
Secondary outcomes
1
Description
Time to start pain
Timepoint
Monthly
Method of measurement
Questionnaire before and after menstruation
2
Description
Menstrual status
Timepoint
Monthly
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group:Group receiving 50,000 mg of vitamin D gelatin capsule available from a pharmacy for three months to evaluate the duration and severity of dysmenorrhea
Category
Treatment - Drugs
2
Description
Intervention group:Group receiving vitamin E400 gelatin capsule, made by Dana Company in Iran for three months to evaluate the duration and severity of dysmenorrhea
Category
Treatment - Drugs
3
Description
Intervention group:Group receiving vitamin D and vitamin E gelatin capsules for three months to evaluate the duration and severity of dysmenorrhea
Category
Treatment - Drugs
4
Description
Control group: Group receiving placebo for three months to evaluate the duration and severity of dysmenorrhea
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Treatment Kowsar Center
Full name of responsible person
Tahereh Behroozi Lak
Street address
Urmia, Resalat Blvd, the end of Jahad St. Urmia University of Medical Science
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3224 0166
Email
t.bahrooz2@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
Mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
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
Oroumia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7707
Email
t.behrooz2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Educational and Treatment Kowsar Center
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3224 0166
Email
t.behrooz2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tahereh Behroozi Lak
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Urmia, Resalat Blvd, the end of Jahad St, Research ward, Setad, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7707
Email
t.behrooz2@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data related to the participants' file can be accessed by correspondence by e-mail.
When the data will become available and for how long
Start the access period 6 months after publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The use of data for scientific research on topics related to the objectives of the study is unrestricted.
From where data/document is obtainable
To the person in charge of scientific response using their email
What processes are involved for a request to access data/document
Objectives and proposals should be sent by e-mail upon request by scientific authorities
Comments
In order to empower other researchers in the field of obstetrics and gynecology, we are ready to work with respected researchers.