Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT00703092
Status:
TERMINATED
Last Update Posted:
2017-10-09
First Post:
2008-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jnestler@mcvh-vcu.edu', 'phone': '804-828-3389', 'title': 'Dr. John Nestler', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fiber-Stat', 'description': '2 tablespoons daily\n\nFiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber-Stat', 'description': '2 tablespoons daily\n\nFiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.'}], 'timeFrame': '10 months', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.'}, {'type': 'SECONDARY', 'title': 'Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fiber-Stat', 'description': '2 tablespoons daily\n\nFiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.'}], 'timeFrame': '10 months', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fiber-Stat', 'description': '2 tablespoons daily\n\nFiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fiber-Stat', 'description': '2 tablespoons daily\n\nFiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'P.I. left University. Study terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2008-06-20', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2008-06-20', 'lastUpdatePostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-27', 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Quantify Enrollment Strategies, Retention, Compliance, Participant Characteristics, and Data Collection Challenges.', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PCOS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vcu.edu/pcos', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45\n* Less than or equal to 8 periods annually\n* elevated serum free testosterone concentrations\n* normal thyroid function tests and serum prolactin\n* exclusion of late-onset adrenal hyperplasia\n* acceptable health based on interview, medical history,physical examination, and lab tests\n* ability to comply with the requirements of the study\n* ability and willingness to provide signed, witnessed informed consent\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease\n* high blood pressure\n* 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)\n* documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism\n* ingestion of any investigational drugs within 4 weeks prior to study onset\n* pregnancy or lactation(less than or equal to 6 weeks postpartum)'}, 'identificationModule': {'nctId': 'NCT00703092', 'briefTitle': 'Pilot Study:Role of Dietary Fiber in PCOS Anovulation', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Pilot Study: Role of Dietary Fiber in PCOS Anovulation', 'orgStudyIdInfo': {'id': 'HM11246'}, 'secondaryIdInfos': [{'id': '2U54HD034449', 'link': 'https://reporter.nih.gov/quickSearch/2U54HD034449', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber-Stat', 'description': '2 tablespoons daily', 'interventionNames': ['Drug: Fiber-Stat']}], 'interventions': [{'name': 'Fiber-Stat', 'type': 'DRUG', 'description': 'Liquid fiber supplement, 2 tablespoons twice daily.', 'armGroupLabels': ['Fiber-Stat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'VCU General Clinical Research Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Paulina A Essah, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}