Flaxseed Lignan (Brevail)
This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
Samuel Kim, MD
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01396369
First received: July 14, 2011
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
PCOS is a disorder which is characterized by hyperandrogenism (high serum male hormone levels), ovulatory dysfunction, and polycystic ovaries (multiple follicles-over 12- in the ovary). There is no universally accepted definition for PCOS. The Rotterdam criteria require 2 of 3 criteria for diagnosis, including hyperandrogenism (clinical hirsutism or serum hormone measurement), oligomenorrhea/amenorrhea, and ultrasound findings of polycystic ovaries.
This study is a prospective randomized pilot study designed to evaluate the effects of flaxseed supplementation (with Brevail) on hormonal and lipid metabolism balance in polycystic ovarian syndrome (PCOS) patients.
| Condition | Intervention |
|---|---|
|
Polycystic Ovarian Syndrome |
Drug: Birth control Drug: Birth control plus Brevail |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Impact of Flaxseed Lignan (Brevail) on Polycystic Ovarian Syndrome |
Resource links provided by NLM:
Further study details as provided by University of Kansas:
Primary Outcome Measures:
- Primary outcomes to assess are the changes of testosterone levels and hirsutism. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary outcomes to assess are the lipid profile and estrogen levels. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Birth control |
Drug: Birth control
In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
|
| Experimental: Birth control plus Brevail |
Drug: Birth control plus Brevail
In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must be 18 to 40 year old female with:
- Diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually/interval over 40 days), Ferriman-Galleway score >8, and/or hyperandrogenemia defined as total testosterone >80ng/dl or bioavailable testosterone >8.4 ng/dl.
- Mentally competent.
Exclusion Criteria:
- Use of oral contraceptives, spironolactone, or insulin-sensitizing agents within the past 2 months.
- Long-term or chronic use of oral antibiotics.
- Hysterectomy.
- FSH >15.
- Pregnancy/lactation.
- Consumption of flaxseed within the last month.
- Diagnosis of thyroid disease, nonclassical adrenal hyperplasia, and hyperprolactinemia.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396369
Contacts
| Contact: Sam Kim, MD | 913-588-2229 | skim2@kumc.edu |
Locations
| United States, Kansas | |
| The University of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Sam Kim, MD 913-588-2229 skim2@kumc.edu | |
| Principal Investigator: Sam Kim, MD | |
Sponsors and Collaborators
Samuel Kim, MD
Investigators
| Principal Investigator: | Sam Kim, MD | The University of Kansas Medical Center |
More Information
No publications provided
| Responsible Party: | Samuel Kim, MD, Associate Professor, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT01396369 History of Changes |
| Other Study ID Numbers: | 12459 |
| Study First Received: | July 14, 2011 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013