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Pilot Study:Role of Dietary Fiber in PCOS Anovulation

This study has been terminated.
(P.I. left University. Study terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00703092
First Posted: June 23, 2008
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University
  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: None (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 ]

Secondary Outcome Measures:
  • Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges. [ Time Frame: 10 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703092


Locations
United States, Virginia
VCU General Clinical Research Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00703092     History of Changes
Other Study ID Numbers: HM11246
2U54HD034449 ( U.S. NIH Grant/Contract )
First Submitted: June 20, 2008
First Posted: June 23, 2008
Results First Submitted: May 27, 2014
Results First Posted: June 30, 2014
Last Update Posted: October 9, 2017
Last Verified: September 2017

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