Pilot Study:Role of Dietary Fiber in PCOS Anovulation

This study has been terminated.
(P.I. left University. Study terminated)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00703092
First received: June 20, 2008
Last updated: June 27, 2014
Last verified: June 2014
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study: Role of Dietary Fiber in PCOS Anovulation

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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 ]

Enrollment: 2
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fiber-Stat
2 tablespoons daily
Drug: Fiber-Stat
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Virginia
VCU General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Paulina A Essah, M.D. Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00703092     History of Changes
Other Study ID Numbers: VCU IRB HM11246, 2U54HD034449
Study First Received: June 20, 2008
Results First Received: May 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anovulation
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases

ClinicalTrials.gov processed this record on October 23, 2014