Objectives: this article is aimed to study the effects of two different drugs in menstrual cycle. The research was done with a focus to 20 to 40 years old patients who had referred to Kosar hospital and were diagnosed PCO by criteria Rotherdam 2003 with symptoms such as anovulation or chronic oligomenorrhea. Design: randomized, single-blind, single-center. Setting and conduct: group A, calcium D pills and group B, metformin tablets is administered. Participants including major eligibility criteria: Inclusion criteria include presence of polycystic ovary and anovulation or choronic oligomenorrhea; exclusion criteria include thyroid disorders and hyperprolactinemia. Intervention: calcium D group (A), 1000mg calcium, vitamin D 400 IU and metformin group (B), 500mg metformin 3 times per day for a six months period is administered. Main outcome measures variable: menstrual cycle is evaluated after consumption of drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705084850N4
Registration date:2017-06-25, 1396/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Shokoh Alsadat Haji Seyed Abotorabi
Name of organization / entity
Qazvin,University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1369 0035
Email address
shabotorabi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Qazvin University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of administration Calcium-Vitamin D and Metformin in Regulating Menstrual Cycle in Polycystic Ovarian Syndrome
Public title
Comparison of the effect of administration Calcium-Vitamin D and Metformin in Regulating Menstrual Cycle in person with an ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the patient with pcos according to roterdam 2003 criteria with anovulation and chronic oligo ovulation and Exclusion criteria: are hyperparathyroidism; hyperprolactinemia.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2011-08-17, 1390/05/26
Ethics committee reference number
20/3271/د
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Mean of interval menstrual cycles
Timepoint
Interval menstrual cycles
Method of measurement
Questionnaire
Secondary outcomes
1
Description
menstrual cycles interval
Timepoint
In six menstrual cycles
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention/Control 1: Calcium-D tablet (1000mg Calcium, Vitamin D 400 IU)
Category
Treatment - Drugs
2
Description
Intervention/Control 2: Metformin tablet 500 mg 3 times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr Shokohossadat Abotorabi
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 of Qazvin 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
Kowsar Hospital
Full name of responsible person
Dr Shokohossadat Abotorabi
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
002832236374
Fax
Email
shabotorabi@qums.ac.irabotorabi4242@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Shokohossadat Abotorabi
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
002832236374
Fax
Email
shabotorabi@qums.ac.irabotorabi4242@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Shokohossadat Abotorabi
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
002832236374
Fax
Email
shabotorabi@qums.ac.ir
abotorabi4242@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)