The effect of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
The effect of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 72 patients. Block method was used for randomization
Settings and conduct
A randomized clinical trial study was performed in Golestan province, Gorgan, Taleghani Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Definitive diagnosis of PCOS based on Rotterdam criteria
- Age 18 to 40 years
Exclusion criteria :
- Pregnancy
- Adrenal hyperplasia
-Androgen-secreting tumors
- Hyperprolactinemia
- Thyroid dysfunction
- Diabetes
- Receiving antioxidant and anti-inflammatory supplements 3 months before the start of the study
Intervention groups
The intervention group received 250 mg / day magnesium oxide (Twenty First Century Pharmaceutical Company, AZ, USA) plus 400 international units of vitamin E per day (Zahravi Pharmaceutical Company, Tabriz, Iran) for 12 weeks.
Main outcome variables
The effect of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220102053603N1
Registration date:2022-03-14, 1400/12/23
Registration timing:prospective
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Maryam Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 977 1393
Email address
ykml@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
Public title
The effect of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome referred to Nahal Infertility Treatment Center, Gorgan in 2021
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of PCOS based on Rotterdam criteria
Age 18 to 40 years
Exclusion criteria:
Pregnancy
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinemia
Thyroid dysfunction
Diabetes
Receiving antioxidant and anti-inflammatory supplements 3 months before the start of the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
38
The study population included all women with PCOS referred to Nahal Infertility Treatment Center in Gorgan, Shahid Sayad Shirazi Hospital in 2021
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks
A for intervention and B for placebo
B A B A 2) B B A A 1)
B A A B 4) A B B A 3)
A A B B 6) A B A B 5)
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients and physicians evaluating the designed interventions in the study or the post-project outcomes will not be aware of the group in which the patient is being examined.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.GOUMS.REC.1400.252
Health conditions studied
1
Description of health condition studied
Hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Hormonal status and biomarkers of inflammation and oxidative stress
Timepoint
12 weeks after taking the supplement
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 250 mg magnesium oxide per day (Twenty First Century Pharmaceutical Company, AZ, USA) plus 400 international units of vitamin E per day (Zahravi Pharmaceutical Company, Tabriz, Iran) for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: They received placebo (Barij Essence Pharmaceuticals, Kashan, Iran) for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Mahbobeh Azadehrah
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
ykml@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Fax
+98 17 3245 1657
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Gorgan University of Medical Sciences
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
ykml@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gorgan University of Medical Sciences
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
ykml@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Maryam Kamali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
ykml@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
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of data to complete the research process on the effects of magnesium and vitamin E supplementation on hormonal status and biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome
From where data/document is obtainable
Contact the author of the article responsible for the research project data.
What processes are involved for a request to access data/document
Contact the author of the article responsible for the research project data.Specify the type of results requested.