Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

March 8, 2015 updated by: Leila Azadbakht, Isfahan University of Medical Sciences

Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of
        • Recruiting
        • Isfahan University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Ahmad Esmaeilzadeh, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnesium Oxide
magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet
Dietary supplement: Magnesium Oxide
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.
Placebo Comparator: Placebo
Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum insulin level
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin Resistance
Time Frame: 8 weeks
8 weeks
Fasting Blood Sugar
Time Frame: 8 weeks
8 weeks
Quantitative insulin sensitivity check index (Quicki)
Time Frame: 8 weeks
8 weeks
HOMA-IR
Time Frame: 8 weeks
8 weeks
HOMA-B
Time Frame: 8 weeks
8 weeks
High Density Lipoprotein
Time Frame: 8 weeks
8 weeks
Low Density Lipoprotein
Time Frame: 8 weeks
8 weeks
Triglyceride
Time Frame: 8 weeks
8 weeks
Total Cholesterol
Time Frame: 8 weeks
8 weeks
Androgen
Time Frame: 8 weeks
8 weeks
Testosterone
Time Frame: 8 weeks
8 weeks
C-Reactive Protein
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Chair: Ahmad Esmaeilzadeh, professor, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 26, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

June 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 8, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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