polycystic ovary syndrome. polycystic ovary syndrome
Conditions
Interventions
Intervention 1: Vitamin D group: received one vitamin D capsule (Zahravi Pharmaceutical Company, Tehran, Iran) (50000 IU/weekly) + two placebo capsules (paraffin oil
daily). Intervention 2: Omega-3 (O3) group: received two O3 capsules (Zahravi Pharmaceutical Company, Tehran, Iran) daily (each one contained 360 mg eicosapentaenoic acid (EPA) and 240 mg docosahexaen
weekly). Intervention 3: Vitamin D + O3 group: received one vitamin D capsule (50000 IU/weekly) + two O3 capsules daily (each one contained 360 mg EPA and 240 mg DHA ). Intervention 4: Placebo group:
weekly) + two placebo capsule (paraffin oil
daily).
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: This syndrome is defined by the Rotterdam Diagnostic Criteria by Gynecologist Excluding any drug or surgical treatment to treat clinical symptoms associated with polycystic ovary syndrome except ocp No history of any allergy, intolerance or harmful drug reaction to the studied supplements Age range ..18-45 Being within the BMI range of 18.5-40 Ability to understand study objectives and provide written informed consent Residence in Shiraz and willingness to participate in the study
Exclusion criteria
Exclusion criteria: Suffering from hormonal disorders including Edison's disease, Cushing's disease, hyperparathyroidism, hypo- or hyperthyroidism Having history of chronic diseases including cancer, heart disease, diabetes, stroke, fibromyalgia, kidney, or liver defects Having history of food and drug allergies Starting drug or surgical therapy for clinical symptoms associated with PCOS except oral contraceptive pills (OCPs) Smoking or any drug addiction Pregnancy and lactation Being on a special diet in the last year Using any dietary supplement, Having oral or injectable nutritional supplements containing vitamin D in the last 3 months Consuming nutritional supplements containing fish oil or Omega-3 fatty acids in the last 3 months Having fish in the diet more than 3 servings per week during last 3 months History of severe side effects or symptoms of poisoning with the current study supplements Lack of adherence to the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TG. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer.;TC:total cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer.;HDL-C:high-density lipoprotein cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer.;LDL-C:Low-density lipoprotein cholesterol. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormone binding globulin :SHBG. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: ELISA.;FBS: fasting blood sugar. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Autoanalyzer.;Physical Activity. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: questionnaire.;Weight. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Low-weight, no-shoe weight using Digital Balance Digital Balance.;BMI:body mass index. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Formula.;WC: Waist circumference. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Meter.;Homeostasis model assessment insulin resistance (HOMA-IR). Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: Formula.;Serum Insulin. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: ELISA.;Height. Timepoint: Beginning and end of the study (first week and eighth week). Method of measurement: With minimum coverage and no shoes, using wall meter. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Maryam Ekramzade
Shiraz University of Medical Sciences
Outcome results
None listed