Status:
TERMINATED
Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
Lead Sponsor:
Duke University
Conditions:
Polycystic Ovarian Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ov...
Eligibility Criteria
Inclusion
- limited to women aged 18-45
- diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually), Ferriman-Gallwey score \> 8, and/or hyperandrogenemia defined as bioavailable T\>8.4ng/dL (Zawdaki \& Dunaif 1992)
- mentally competent
- English speaking/writing
- telephone access and/or email access
Exclusion
- Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the past 3 months;
- Long-term or chronic use of oral antibiotics;
- Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal hyperplasia;
- Hysterectomy;
- Onset of menopause;
- Pregnancy/Lactation;
- Consumption of flaxseed within the past month; and
- Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00693082
Start Date
August 1 2007
End Date
June 1 2009
Last Update
November 20 2012
Active Locations (1)
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1
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27710