Study Stopped
P.I. left University. Study terminated
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Pilot Study: Role of Dietary Fiber in PCOS Anovulation
2 other identifiers
interventional
2
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
June 30, 2014
CompletedOctober 9, 2017
September 1, 2017
2.1 years
June 20, 2008
May 27, 2014
September 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Generate Preliminary Data on the Range of Outcome Measures at Baseline and After 6 Months of Fiber Supplementation in Terms of: Ovulation Rates, Insulin Sensitivity, Concentrations of Circulating Androgens and Satiety.
10 months
Secondary Outcomes (1)
Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
10 months
Study Arms (1)
Fiber-Stat
EXPERIMENTAL2 tablespoons daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VCU General Clinical Research Center
Richmond, Virginia, 23298, United States
Related Links
Results Point of Contact
- Title
- Dr. John Nestler
- Organization
- Virginia Commonwealth University
Study Officials
- PRINCIPAL INVESTIGATOR
Paulina A Essah, M.D.
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 23, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
October 9, 2017
Results First Posted
June 30, 2014
Record last verified: 2017-09