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Pilot Study:Role of Dietary Fiber in PCOS Anovulation

NCT ID: NCT00703092

Last Updated: 2017-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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PCOS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fiber-Stat

2 tablespoons daily

Group Type EXPERIMENTAL

Fiber-Stat

Intervention Type DRUG

Liquid fiber supplement, 2 tablespoons twice daily.

Interventions

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Fiber-Stat

Liquid fiber supplement, 2 tablespoons twice daily.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paulina A Essah, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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VCU General Clinical Research Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Related Links

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http://www.vcu.edu/pcos

Related Info

Other Identifiers

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2U54HD034449

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM11246

Identifier Type: -

Identifier Source: org_study_id