Status:
COMPLETED
n-3 Polyunsaturated Fatty Acids (PUFA) Supplementation in Young Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
The Adelaide and Meath Hospital
Collaborating Sponsors:
University College Dublin
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This is a dietary intervention study designed to assess the impact of long chain (LC) n-3 polyunsaturated fatty acids (PUFA) in young women with polycystic ovary syndrome (PCOS). Considering that LC n...
Detailed Description
Polycystic ovary syndrome (PCOS) is a chronic condition affecting young women of reproductive age. Long-term, safe and efficacious treatments are needed for women with this condition, and dietary ther...
Eligibility Criteria
Inclusion
- Had a positive diagnosis of PCOS as defined according to the NIH criteria as chronic oligomenorrhoea (\< 9 menstrual cycles per year) and clinical and/or biochemical evidence of hyperandrogenism, in the absence of other disorders causing the same phenotype. Clinical criteria included hirsutism with a Ferriman-Galwey score greater than 9, acne or male pattern alopecia; biochemical criteria included total-testosterone, androstenedione or dehydroepiandrosterone sulphate (DHEAS) greater than the laboratory reference range.
- Were between the ages of 18 and 40
Exclusion
- Were under 18 years or greater than 40 years old,
- Were non-Caucasian
- Were pregnant, lactating or trying to conceive
- Had a body mass index (BMI) \<18kg/m2 or \>50kg/m2
- Had a recent illness or any chronic illness likely to influence results
- Were taking any medications likely to influence the results including hormonal contraception, antihypertensives, lipid lowering medications, antiplatelet agents, anti-inflammatory agents
- Were taking nutritional supplements
- Consumed greater than 2 portions of oily fish per week
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01189669
Start Date
September 1 2007
End Date
July 1 2008
Last Update
September 13 2010
Active Locations (2)
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1
Diabetes Day Centre, The Adelaide and Meath Hospital
Dublin, Dublin, Ireland, 24
2
Nutrigenomics Research Group, UCD
Dublin, Dublin, Ireland, 4