Effects of administration of CoQ10 alone or combined with Vitamin E in patients with polycystic ovary syndrome

Effects of administration of CoQ10 alone and combined with Vitamin E on nutritional status and serum levels of sex hormones and adipokines in patients with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201610193140N18

Enrollment

Registered

2016-12-04

Start date

2016-12-10

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: CoQ10 (200 mg/day) and vitamin E placebo. The dose of coq10 supplements is 100 mg/day and patients will consume twice a day. Placebo will be produced as soft gel, without effective mat

Placebo

CoQ10 (200 mg/day) and vitamin E placebo. The dose of coq10 supplements is 100 mg/day and patients will consume twice a day. Placebo will be produced as soft gel, without effective material. The place

CoQ10 placebo and vitamin E (400IU/day). The dose of vitamin E supplement is 400 IU/day and patients will consume once a day. The placebo is filled with edible paraffin wax and exactly similar to sup

Co-administration of coQ10 (200 mg/day) and Vitamin E (400 IU/day). The dose of coQ10 supplement is 100 mg and patients will consume twice a day. The dose of vitamin E is 400 IU and patients will cons

Vitamin E and CoQ10 placebo. Placebo will be produced as soft gel, without effective material. The placebo is filled with edible paraffin wax and is made exactly similar to supplements. The placebo w

Eligibility

Sex/Gender

Female

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 20–40 year old females with PCOS, BMI in the range of 25-35 kg/m2. Non Inclusion criteria: history of thyroid disorder; diabetes; cardiovascular; metabolic; renal; liver diseases; Cushing syndrome; smoking; alcohol consumption; adherence to a specific diet and consumption of any dietary supplements including antioxidants for 3 months prior to the study; hormone therapy; hyperprolactinemia; pregnancy; lactation; menopause.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Anthropometric indices. Timepoint: Before and after the intervention. Method of measurement: Stadiometer, Scale, Tape.;Dietary intakes. Timepoint: Before and after intervention. Method of measurement: 24 hr dietary recall questionnaire.;Blood levels of glucose. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of insulin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Insulin resistance index. Timepoint: Before and after the intervention. Method of measurement: Formula.;Blood levels of triglycerides. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of LDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of HDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of total cholestrol. Timepoint: Before and after intervention. Method of measurement: Friedewald formula.;Serum levels of adipolin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of chemerin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of testostrone hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of sex hormone binding globulin (SHBG). Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of LH hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of FSH hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Added at 2017-04-08: inflammatory markers. Timepoint: Added at 2017-04-08: before and after intervention. Method of measurement: Added at 2017-04-08: ELISA.;Added at 2017-04-08: endothelial function markers. Timepoint: Added at 2017-04-08: before and after intervention. Method of measure	—

Measure

Time frame

Anthropometric indices. Timepoint: Before and after the intervention. Method of measurement: Stadiometer, Scale, Tape.;Dietary intakes. Timepoint: Before and after intervention. Method of measurement: 24 hr dietary recall questionnaire.;Blood levels of glucose. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of insulin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Insulin resistance index. Timepoint: Before and after the intervention. Method of measurement: Formula.;Blood levels of triglycerides. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of LDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of HDL-cholestrol. Timepoint: Before and after the intervention. Method of measurement: Enzymatic method.;Blood levels of total cholestrol. Timepoint: Before and after intervention. Method of measurement: Friedewald formula.;Serum levels of adipolin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of chemerin. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of testostrone hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of sex hormone binding globulin (SHBG). Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of LH hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Serum levels of FSH hormone. Timepoint: Before and after the intervention. Method of measurement: ELISA KIT.;Added at 2017-04-08: inflammatory markers. Timepoint: Added at 2017-04-08: before and after intervention. Method of measurement: Added at 2017-04-08: ELISA.;Added at 2017-04-08: endothelial function markers. Timepoint: Added at 2017-04-08: before and after intervention. Method of measure

—

Secondary

Measure	Time frame
Serum values of COQ10. Timepoint: before and after intervention. Method of measurement: ELISA kit.;Systolic and diastolic blood pressure. Timepoint: before and after intervention. Method of measurement: Digital monometer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzimeh Izadi

Faculty of Nutrition ana Food Science, Tabriz University of Medical Sciences

izadia@tbzmed.ac.ir, izadi.sahar7@gmail.com+98 41 3335 5921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 16, 2026