effect of Supplementation in combination with diet therapy in treatment of polycystic ovary syndrome

Phase 2

• Conditions: Polycystic ovary syndrome.; Sclerocystic ovary syndrome? Stein-Leventhal syndrome

• Registration Number: IRCT2016062710826N19
• Lead Sponsor: Vice chancellor for research?Sahid Sadoughi University of Medical Sciences Yazd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

aged 18-40 years old, Patients with PCOS according to Rotterdam criteria, BMI between 25 to 40, Serum vitamin D levels less than 20 ng /ml, not using weight loss diet and vitamin D supplement Over the last 3 months, not using hormone therapy, not using certain drugs including Weight loss drugs and multivitamin supplements mineral, not smoking, not doing heavy and professional exercise. Exclusion criteria: individuals with diabetes,
Cardiovascular disease, Liver, kidney, thyroid and para- thyroid, Cushing's syndrome, osteomalacia, changes in physical activity, Non-compliance with diet and supplementation

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?DHEA ( Dehydroepiandrosterone sulfate). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Total testosterone. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;SHBG (sex hormone-binding globulin ). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.;Percent of body fat, percent of free fat mass. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Body composition device.

Secondary Outcome Measures

Name	Time	Method
Free androgen index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Total testosterone/ SHBG.;Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: OMRON scale with an accuracy of 0.1kg.;Body Mass Index. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: weight/ height*height.;Waist circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;Hip circumference. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: By meter in cm.;25OHD (25-hydroxy vitamin D). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Elisa method.