Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00693082 |
Recruitment Status :
Terminated
(recruitment and pilot funding issues)
First Posted : June 6, 2008
Last Update Posted : November 20, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovarian Syndrome | Dietary Supplement: flaxseed | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Dietary Supplement: flaxseed
1 tablespoon a day for first three days, increasing to two tablespoons a day for the next three days. On the 7th day start with 3 tablespoons per day and maintain dose throughout the duration of the study (11 weeks). |
- To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS. [ Time Frame: baseline, 12 weeks, 24 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693082
United States, North Carolina | |
Duke Univeristy Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Susan M Schneider, PhD | Duke University |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT00693082 |
Other Study ID Numbers: |
Pro00000854 |
First Posted: | June 6, 2008 Key Record Dates |
Last Update Posted: | November 20, 2012 |
Last Verified: | November 2012 |
PCOS flaxseed |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Gonadal Disorders Endocrine System Diseases |