Polycystic ovarian syndrome. Sclerocystic ovary syndrome Stein-Leventhal syndrome
Conditions
Interventions
Intervention 1: Zinc Sulfate one capsule a day for 8 weeks, (220 mg zinc sulphate capsule (50 mg elemental zinc). Intervention 2: Placebo one capsule a day for 8 weeks (insoluble corn starch).
Treatment - Drugs
Placebo
Zinc Sulfate one capsule a day for 8 weeks, (220 mg zinc sulphate capsule (50 mg elemental zinc)
Placebo one capsule a day for 8 weeks (insoluble corn starch)
Sponsors
1) Vice-chancellor for research of Tabriz University of Medical Sciences 2)Tabriz Nutrition Researc
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Women with PCOS diagnosed by the Rotterdam consensus criteria (Presence of 2 of the following 3 conditions: i. Oligo/anovulation ii. clinical or biochemical evidence of hyperandrogenism iii. Polycystic ovaries on ultrasound examination), age 20-45 years, BMI = 25, moderate activity Exclusion criteria: Any disease that influence metabolic parameters in this trial (liver, cardiovascular, kidney or gastrointestinal diseases, hypo/hyper thyroidism, hyperprolactinemia, congenital adrenal hyperplasia, Cushing’s syndrome, androgen secreting tumors), insulin consumption, receiving antihypertension drugs, pregnancy, breast feeding, receiving any vitamin or mineral supplements, any special diet.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Zinc serum value. Timepoint: Baseline and at the end of intervention. Method of measurement: atomic absorption spectrophotometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting serum insulin values. Timepoint: Baseline and at the end of intervention. Method of measurement: commercial kits special to assess insulin values .ELISA.;Insulin resistance index. Timepoint: Baseline and at the end of intervention. Method of measurement: with HOMA formula.;Serum inflammatory values (IL-6, hs-CRP). Timepoint: Baseline and at the end of intervention. Method of measurement: hs-CRP assess with immunotorbidometric method andIL-6 with elayza method.;Fasting serum glucose values. Timepoint: Baseline and at the end of intervention. Method of measurement: Enzymatic method, automatic analyzer.;Fasting srum lipid profile (LDL,HDL,total cholesterol,TG). Timepoint: Baseline and at the end of intervention. Method of measurement: Enzymatic method, with special kits for assessing TG, HDL, total cholestrol and Friedewald equation for assessing LDL cholestrol.;Systolic and diastolic Blood pressure. Timepoint: Baseline and at the end of intervention. Method of measurement: mercury sphygmomanometer.;Antropometric indicators (weight-height-BMI-Waist circumference-hip circumference-WHR). Timepoint: Baseline and at the end of intervention. Method of measurement: Waist and hip circumference measure with a plastic tape meter.Body weight without shoes with calibrated scale accurate to 0.1 kg.Standing height without shoes or socks measureto the nearest 0.1 cm with a stadiometer mounted on a wall.BMI calculated with this equation:W(kg) /H(m)2. WHR calculated with waist circumference/hip circumference. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Pourteymour farde tabriz
Tabriz University of Medical Sciences
Outcome results
None listed