Protocol summary

Study aim
Determination and comparison of menstrual disorders,Androgenic alopecia,quality of life scores,the amount of acne, serum magnesium concentration, number of cysts in each ovary in the two groups of intervention and placebo before and after the intervention
Design
Clinical trial with control group, with parallel group, double-blind, randomized,Single phase on 70 patients . For randomization we use SPSS software version 25
Settings and conduct
70 women with PCOS referred to Al-Zahra and Shahid Beheshti hospitals in Isfahan will be divided into two groups of 35. The studied variables will be measured in all individuals, then for ten weeks one group with magnesium supplement and the other group with placebo. They will be supplemented bable blind method and after the supplementation period, the variables will be measured and examined again.
Participants/Inclusion and exclusion criteria
Women 18 to 45 years old with PCOS BMI between 5/18 to 30 Do not change the dose of the drug or start taking a new drug in the last two weeks Absence of menopause No hypothyroidism Do not take vitamin and mineral supplements
Intervention groups
Eligible written consent will be obtained from eligible individuals who wish to participate in the study. Individuals are also asked to complete a questionnaire on demographic information, medical history, and medications. Then, using SPSS software and based on the code assigned to each person, people are randomly divided into two groups of intervention and control. Using stratified randomization, the ratio of people with body mass index between 18.5 to 24.9 and people with body mass index between 25 and 29.9 will be the same in both groups.
Main outcome variables
Get magnesium supplements; Menstrual disorders; Androgenic alopecia; Acne; Quality of Life; Number of cysts; Serum magnesium levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130903014551N9
Registration date: 2020-10-18, 1399/07/27
Registration timing: prospective

Last update: 2020-10-18, 1399/07/27
Update count: 0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of magnesium supplementation on menstrual disorders, androgenic alopecia, quality of life and acne in women with poly cystic ovary syndrome
Public title
Effect of magnesium on poly cystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18 to 45 years old with PCOS BMI between 5/18 to 30 Do not change the dose of the drug or start taking a new drug in the last two weeks Absence of menopause Absence of hypothyroidism Do not take vitamin and mineral supplements
Exclusion criteria:
Failure to follow nutritional recommendations and interventions Failure to refer the person in the next steps Change the dose of the drug or start taking a new drug that affects the indicators of the study Having a specific disease that disrupts the study process Occurrence of menopause
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block randomization method (permuted blocked randomization). depending on the sample size , each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
For double blinding of this study, at the beginning, cans contained magnesium supplement and placebo were coded as A and B by person other than researcher to ensure researcher and participants were not informed about types of supplement received by participants
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Services, Building No. 4 - Vice Chancellor for Research and Technology
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.406

Health conditions studied

1

Description of health condition studied
poly cystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Menstrual disorder
Timepoint
Before and after intervention
Method of measurement
Based on standard definitions provided by the International Federation of Gynecology and Obstetrics

2

Description
androgenic alopecia
Timepoint
Before and after intervention
Method of measurement
Sinclair Scale

3

Description
quality of life
Timepoint
Before and after intervention
Method of measurement
Health Survey Questionnaire (SF-36

4

Description
acne
Timepoint
Before and after intervention
Method of measurement
GAGS (global acne grading system) method

5

Description
Number of ovarian cysts
Timepoint
At the beginning and end of the intervention
Method of measurement
sonography

Secondary outcomes

1

Description
Physical activity
Timepoint
In the second,forth,sixth,eighth and tenth weeks
Method of measurement
Physical activity record questionnaire

2

Description
Dietary intake
Timepoint
In the second,forth,sixth,eighth and tenth weeks
Method of measurement
food record

3

Description
Serum magnesium concentration
Timepoint
At the beginning the intervention, In the fifth week of the intervention
Method of measurement
AAS method

Intervention groups

1

Description
Intervention group: Patients in this group will receive 250 mg magnesium supplement made by Donya Daru Sepehr Company once a day for 10 weeks.
Category
Treatment - Other

2

Description
Control group: Patients in this group will receive a placebo that contains starch and is made by Barij Essanss Company once a day for 10 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
Hatav Ghasemi Tehrani
Street address
soffe
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/oldsite/undefined/

2

Recruitment center
Name of recruitment center
shahid beheshti hospital of isfahan
Full name of responsible person
Hatav ghasemi tehrani
Street address
ostad motahari
City
isfahan
Province
Isfehan
Postal code
1234567891
Phone
+98 31 3236 7001
Email
info@manoshahr.ir
Web page address
http://manoshahr.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
hezar jarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahsima Jaripur
Position
Executor of plan
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
sepah
City
kashan
Province
Isfehan
Postal code
8714683561
Phone
+98 31 5546 1381
Email
mahsimajaripur@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamad Hossein Rohani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Food and nutrition faculty, Isfahan medical university, hezar jarib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
s_m_rouhani2003@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsima Jaripur
Position
Executor of plan
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
SEpah
City
Kashan
Province
Isfehan
Postal code
8714683561
Phone
+98 31 5546 1381
Email
mahsimajaripur@ut.ac.ir

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
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