CompletedPhase 4

The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome

Australia40 participantsStarted 2008-02

Plain-language summary

We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Overweight/obese women with PCOS as per 1990 NIH criteria (see below) * Non-smokers * Age\>18 years, premenopausal * Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia * Acceptable to be taking the oral contraceptive pill Exclusion Criteria: * Uncontrolled hypertension (BP\>160/100mmHg) * Known co-morbidities including liver or renal disease * Already taking fish oil supplements * Other intercurrent illness (major surgery, CV event) * Smokers * Alcohol intake \>20g/day * Pregnancy * Any metallic implant (contraindication for MRI).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

24 hour ambulatory systolic blood pressure

Timeframe: week 8 and week 24

Trial details

NCT IDNCT00620529

SponsorKeogh Institute for Medical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

View on ClinicalTrials.gov More Polycystic Ovary Syndrome trials