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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Oxide | Active Comparator | magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet |
|
| Placebo | Placebo Comparator | Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Oxide | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum insulin level | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Resistance | 8 weeks | |
| Fasting Blood Sugar | 8 weeks | |
| Quantitative insulin sensitivity check index (Quicki) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Esmaeilzadeh, Professor | Contact | 3117922776 | 0098 | esmaillzadeh@hlth.mui.ac.ir |
| maryam farsinejadmarj, Bachelor | Contact | 9374760794 | 0098 | maryam.farsinejad@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmad Esmaeilzadeh, professor | Isfahan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isfahan University of Medical Sciences | Recruiting | Isfahan | Isfahan | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31960275 | Derived | 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. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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|
| Placebo | Dietary Supplement |
|
| 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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |