Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: Magnesium Oxide
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum insulin level |  | 8 Weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors