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Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation


Phase 2
18 Years
45 Years
Not Enrolling
Female
Polycystic Ovarian Syndrome

Thank you

Trial Information

Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.

Outcome Time Frame:

baseline, 12 weeks, 24 weeks

Safety Issue:

No

Principal Investigator

Susan M Schneider, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00000854

NCT ID:

NCT00693082

Start Date:

August 2007

Completion Date:

June 2009

Related Keywords:

  • Polycystic Ovarian Syndrome
  • PCOS
  • flaxseed
  • Polycystic Ovary Syndrome

Name

Location

Duke Univeristy Medical CenterDurham, North Carolina  27710