Pilot Study:Role of Dietary Fiber in PCOS Anovulation

This study is not yet open for participant recruitment.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March 2008

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00703092

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).

Condition	Intervention	Phase
PCOS	Drug: Fiber-Stat	Phase IV

MedlinePlus related topics: Dietary Fiber

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Pilot Study: Role of Dietary Fiber in PCOS Anovulation

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantify enrollment strategies, retention, compliance, participant characteristics, and data collection challenges. [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Liquid fiber supplement, 2 tablespoons twice daily.

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703092

Contacts

Contact: Manar T Nazmy	804-827-0171	mtnazmy@vcu.edu
Contact: Terre Y Williams	804-828-2663	tywillia@vcu.edu

Locations

United States, Virginia
Virginia Commonwealth University General Clinical Research Center
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Paulina A Essah, M.D.

Virginia Commonwealth University

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Virginia Commonwealth University ( Paulina A. Essah, M.D. )
Study ID Numbers:	VCU IRB HM11246, 2U54HD034449
Study First Received:	June 20, 2008
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00703092
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

Endocrinopathy
Ovarian Diseases
Anovulation

Additional relevant MeSH terms:

Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009