[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582788":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":18,"locations":29,"responsibleParty":56,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Eastern Virginia Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fiber","EXPERIMENTAL","Participants will psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.",[13],"Dietary Supplement: Fiber",{"label":15,"type":16,"description":17,"interventionNames":18},"No Fiber","NO_INTERVENTION","Participants will receive no fiber supplementation capsules.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DIETARY_SUPPLEMENT","Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.",[9],[25],{"name":26,"affiliation":27,"role":28},"Jerri Waller, MD","Macon & Joan Brock Virginia Health Sciences at Old Dominion University","PRINCIPAL_INVESTIGATOR",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Macon & Joan Brock Virginia Health Sciences at ODU","RECRUITING","Norfolk","Virginia","23507","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-76.28522,36.84681,{"lat":42,"lon":41},[45,50,53,54],{"name":46,"role":47,"phone":48,"phoneExt":18,"email":49},"Morgan Scaglione, MD","CONTACT","757-446-7900","scaglima@odu.edu",{"name":51,"role":47,"phone":48,"phoneExt":18,"email":52},"Kristin Ayers, MPH","ayerskl@odu.edu",{"name":26,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":46,"role":55,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":28,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Jerri Waller","Principal Investigator","100582788","effect-of-fiber-supplementation-on-the-need-for-medication-with-gestational-diabetes-100582788",false,"NCT06867861","Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes","Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Singleton gestation\n* Known or new diagnosis of gestational diabetes without reason for medication\n* Age \\>=18 to \\\u003C=50\n\nExclusion Criteria:\n\n* \\- Non-English as primary language.\n* Known or suspected fetal anomaly or aneuploidy.\n* Known lower bowel disorder\n* Known phenylketonuria\n* Prisoners.\n* Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.","FEMALE","18 Years","50 Years",{"count":70,"type":71},110,"ESTIMATED","INTERVENTIONAL",[74],"NA","The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.",[77],"Gestational Diabetes Mellitus (GDM)",[79,9,80],"Gestational Diabetes Mellitus","GDM","2025-03-05",{"date":83,"type":84},"2025-03-10","ACTUAL",{"date":86,"type":84},"2025-02-24",{"date":88,"type":71},"2026-08-26",{"name":5,"class":6},1]