Expired Study
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Richmond, Virginia 23298


Purpose:

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).


Study summary:

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 feasibility of conducting a larger double-blind, randomized trial in women with PCOS to test this hypothesis. We will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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)


Study is Available At:


Original ID:

HM11246


NCT ID:

NCT00703092


Secondary ID:

2U54HD034449


Study Acronym:


Brief Title:

Pilot Study:Role of Dietary Fiber in PCOS Anovulation


Official Title:

Pilot Study: Role of Dietary Fiber in PCOS Anovulation


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Virginia Commonwealth University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

P.I. left University. Study terminated


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Paulina A Essah, M.D.
Principal Investigator
Virginia Commonwealth University

Study Dates

Start Date:February 2008
Completion Date:March 2010
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 8, 2017
First Received Date:June 20, 2008
First Results Date:May 27, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
Time Frame:10 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Time Frame:10 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Fiber-Stat
Description:Liquid fiber supplement, 2 tablespoons twice daily.
Arm Name:Fiber-Stat

Study Arms

Study Arm Type:Experimental
Arm Name:Fiber-Stat
Description:2 tablespoons daily

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Virginia Commonwealth University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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