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Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Magnesium Oxide
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Having PCOS according to the Rotterdam criteria,
  • Age between 20-45 years,
  • Lack of pregnancy and lactation,
  • Not having certain regime during last 3 months,
  • Non-smoking,
  • Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
  • Not taking supplements,
  • Being overweight (Kg / m 25 ≤ BMI)

Exclusion Criteria:

  • Hormone Therapy,
  • Pregnancy and lactation during the study,
  • Severe weight loss (more than 2.5 kg per month) during the study

Sites / Locations

  • Isfahan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium Oxide

Placebo

Arm Description

magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet

Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day

Outcomes

Primary Outcome Measures

Serum insulin level

Secondary Outcome Measures

Insulin Resistance
Fasting Blood Sugar
Quantitative insulin sensitivity check index (Quicki)
HOMA-IR
HOMA-B
High Density Lipoprotein
Low Density Lipoprotein
Triglyceride
Total Cholesterol
Androgen
Testosterone
C-Reactive Protein

Full Information

First Posted
June 26, 2014
Last Updated
March 8, 2015
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02178150
Brief Title
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome
Official Title
Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Oxide
Arm Type
Active Comparator
Arm Description
magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium Oxide
Intervention Description
This is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Serum insulin level
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Insulin Resistance
Time Frame
8 weeks
Title
Fasting Blood Sugar
Time Frame
8 weeks
Title
Quantitative insulin sensitivity check index (Quicki)
Time Frame
8 weeks
Title
HOMA-IR
Time Frame
8 weeks
Title
HOMA-B
Time Frame
8 weeks
Title
High Density Lipoprotein
Time Frame
8 weeks
Title
Low Density Lipoprotein
Time Frame
8 weeks
Title
Triglyceride
Time Frame
8 weeks
Title
Total Cholesterol
Time Frame
8 weeks
Title
Androgen
Time Frame
8 weeks
Title
Testosterone
Time Frame
8 weeks
Title
C-Reactive Protein
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having PCOS according to the Rotterdam criteria, Age between 20-45 years, Lack of pregnancy and lactation, Not having certain regime during last 3 months, Non-smoking, Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid, Not taking supplements, Being overweight (Kg / m 25 ≤ BMI) Exclusion Criteria: Hormone Therapy, Pregnancy and lactation during the study, Severe weight loss (more than 2.5 kg per month) during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Esmaeilzadeh, Professor
Phone
3117922776
Ext
0098
Email
esmaillzadeh@hlth.mui.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
maryam farsinejadmarj, Bachelor
Phone
9374760794
Ext
0098
Email
maryam.farsinejad@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Esmaeilzadeh, professor
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Esmaeilzadeh, professor
Phone
3117922776
Ext
0098
Email
esmaillzadeh@hlth.mui.ac.ir
First Name & Middle Initial & Last Name & Degree
Ahmad Esmaeilzadeh, professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
31960275
Citation
Farsinejad-Marj M, Azadbakht L, Mardanian F, Saneei P, Esmaillzadeh A. Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome. Biol Trace Elem Res. 2020 Aug;196(2):349-358. doi: 10.1007/s12011-019-01923-z. Epub 2020 Jan 20.
Results Reference
derived

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Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

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