Clinical trial NCT00703092: Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Official title: Pilot Study: Role of Dietary Fiber in PCOS Anovulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: PCOS
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-06-23
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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)

Primary outcomes:
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.
timeFrame: 10 months
Secondary outcomes:
measure: Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.
timeFrame: 10 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: VCU General Clinical Research Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paulina A Essah, M.D.
role: PRINCIPAL_INVESTIGATOR
References: