The aim of this study was to evaluate the effect of magnesium supplementation on clinical and metabolic variables in women with PCOS referring to Ayatollah Mousavi Hospital in 1998.
Design
Patients will be grouped according to the Balanced Block Randomization method in groups A and B.The sample number will be 20 in each group.
The study will be three-way blind
Settings and conduct
Patients will be grouped according to the Balanced Block Randomization method into two groups: A and B ، in the magnesium group, magnesium oxide supplement and in the control group only placebo will be administered. Data collection and data analysis are unclear
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with polycystic ovary syndrome based on the Rotterdam Diagnostic Criteria2. Satisfaction with attending the study3. Satisfaction to continue cooperation4. Magnesium does not have a high base normal.
5. There is no history of electrolyte abnormalities associated with potassium or calcium in the patient.Exclusion criteria:
1. Have any use of magnesium contraindications
2. Supplementation within 3 months prior to study
3. Oral contraceptive use within 3 months prior to study4. Thyroid dysfunction5. HyperprolactinemiaDiabetes Mellitus7. Congenital adrenal hyperplasia8. Drugs that affect adrenal and ovarian function and metabolism of carbohydrates and lipids.9. A history of electrolyte abnormalities associated with potassium and calcium
Intervention groups
In the magnesium group, magnesium oxide supplements will be administered to patients, and in the control group, only placebo, produced by the same company, with the same form of magnesium coupling, will beرadministered daily to patients.
Main outcome variables
If magnesium supplements are effective in the treatment of pco, this supplement can be used to treat patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046147N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Shabnam Shahmoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 0932
Email address
ashkanghadimi23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-28, 1398/11/08
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium supplements on clinical and metabolic variables in women with polycystic ovarian syndrome (PCOS)
Public title
The effect of magnesium supplements on polycystic ovarian syndrome (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients with polycystic ovary syndrome based on the Rotterdam Diagnostic Criteria2. Satisfaction with attending the study3. Satisfaction to continue cooperation4. Magnesium does not have a high base normal.5. There is no history of electrolyte abnormalities associated with potassium or calcium in the patient.
Exclusion criteria:
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced Block Randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients are treated with prescribed medication packages by the study supervisor (supervisor). The drug packages are quite similar in form and the patient and the planner are not aware of the contents of the packages. In addition, information is collected, the patients are evaluated and the forms are completed by the planner and his assistant who are not aware of the contents of the packages; The data analysis will also be performed by the design consultant and design consultant who is unaware of the contents of the drug packages and only the patient group (group 1 or 2) is identified to analyze the data, so the study is three-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Gavazang Road - Ayatollah Mousavi Hospital
City
zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.ZUMS.REC.1398.314
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome (PCOS)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in Insulin Resistance Index (HOMA-IR)
Timepoint
FBS and serum insulin are re-administered to patients at baseline and after 2 months of treatment (end of treatment).
Method of measurement
ice.Patients receive fasting insulin for a 12-hour fasting blood sample to measure fasting blood sugar (for diabetes screening).
Secondary outcomes
1
Description
Weight Loss and Blood Glucose and Lipid Profile and Blood Pressure and Menstrual Cycle Adjustment in Magnesium Supplemented Patients
Timepoint
After 2 months of treatment (end of treatment), weight, waist circumference, blood pressure, menstrual pattern and serum levels of FBS, TG, CHOL, LDL, HDL and insulin are monitored again for two months after completion. Patients will be monitored for clinical symptoms including menstruation, weight, waist circumference and blood pressure.
Method of measurement
The pattern of menstrual periods is recorded in a questionnaire designed for the duration and duration of bleeding during the menstrual cycle. After fasting for 12 hours, a blood sample was taken to measure fasting blood sugar (for diabetes screening), fasting insulin and Mg levels, as well as TG, CHOL, HDL and LDL. People are included in the study who do not have high normal magnesium levels. Weight in fasting, without shoes, with minimal clothing and measured using the Seca Digital Balance with a accuracy of 0.1 kg. Height is measured with the help of a tape measure with a accuracy of 0.1 cm. BMI is calculated by dividing the weight in kilograms by the power of 2 heights per meter. Waist circumference greater than 5 cm above the navel and hip circumference less than 5 cm below the navel are measured with tape measure. Patients' blood pressure is measured and recorded with a single device.
Intervention groups
1
Description
Intervention group: In the magnesium group, magnesium oxide supplement made by Galen's company in the form of 250 mg a day for two months will be given to patients and in the control group only placebo produced by the same company with the same form of magnesium catabolic The patient will be prescribed daily.
Category
Treatment - Drugs
2
Description
Control group: In the control group, only placebo, manufactured by Galen's company, in the same form as magnesium chelate, will be administered daily to patients for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Shabnam Shahmoradi
Street address
Gavazang Road - Mousavi Hospital
City
zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Email
mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Gavazang Road
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0651
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?