A Clinical Trial to Measure the Effect of DHA-enriched Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat Content in the Polycystic Ovary Syndrome
The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and
liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We
hypothesise that fish oils will have a beneficial effect on these endpoints and other
cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This
crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils
on the above parameters compared with placebo (olive oil). Subjects with PCOS who have
participated in previous studies with this research group will be approached for
recruitment, as will eligible subjects within the endocrine clinics of the chief and
co-investigators.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
24 hour ambulatory systolic blood pressure
week 8 and week 24
No
Andrea J Cussons, MBBS
Principal Investigator
The University of Western Australia
Australia: Department of Health and Ageing Therapeutic Goods Administration
EC 2008/049
NCT00620529
February 2008
February 2009
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