Status:
TERMINATED
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
PCOS
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).
Detailed Description
We hypothesize that 6 months of fiber supplementation will improve ovulation in women with PCOS by improving insulin sensitivity independent of weight loss. In this pilot study, we will determine the ...
Eligibility Criteria
Inclusion
- Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45
- Less than or equal to 8 periods annually
- elevated serum free testosterone concentrations
- normal thyroid function tests and serum prolactin
- exclusion of late-onset adrenal hyperplasia
- acceptable health based on interview, medical history,physical examination, and lab tests
- ability to comply with the requirements of the study
- ability and willingness to provide signed, witnessed informed consent
Exclusion
- Diabetes mellitus
- Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease
- high blood pressure
- current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, GnRH-agonists, or anti-androgens (spironolactone,flutamide,etc)
- documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism
- ingestion of any investigational drugs within 4 weeks prior to study onset
- pregnancy or lactation(less than or equal to 6 weeks postpartum)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00703092
Start Date
February 1 2008
End Date
March 1 2010
Last Update
October 9 2017
Active Locations (1)
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1
VCU General Clinical Research Center
Richmond, Virginia, United States, 23298