Polycystic Ovary Syndrome
Conditions
Keywords
Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors
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.
Interventions
DIETARY_SUPPLEMENTMagnesium 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.
DIETARY_SUPPLEMENTPlacebo
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum insulin level | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Insulin Resistance | 8 weeks |
| Triglyceride | 8 weeks |
| Total Cholesterol | 8 weeks |
| Androgen | 8 weeks |
| Testosterone | 8 weeks |
| C-Reactive Protein | 8 weeks |
| Low Density Lipoprotein | 8 weeks |
Countries
Iran
Contacts
Primary ContactAhmad Esmaeilzadeh, Professor
Backup Contactmaryam farsinejadmarj, Bachelor
Outcome results
None listed