[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597667":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Iron supplementation arm","EXPERIMENTAL","Participants in the iron supplementation arm will receive 3 months of iron supplementation treatment",[13],"Dietary Supplement: Ferrous Sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","Participants in the placebo arm will receive 3 months of placebo treatment",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Ferrous Sulfate","Dosing of the iron supplement will be based on weight.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo pills will be provided to participants in the placebo arm",[15],[32],{"name":33,"affiliation":5,"role":34},"Alison E Pritchard, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","443-904-2488","pritchard@kennedykrieger.org",[41],{"facility":42,"status":26,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Kennedy Krieger Institute","Baltimore","Maryland","21231","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.61219,39.29038,{"lat":52,"lon":51},[55],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100597667","phase-1-a-clinical-trial-of-iron-supplementation-for-youth-with-adhd-and-restless-sleep-100597667",false,"NCT07061470","A Clinical Trial of Iron Supplementation for Youth With ADHD and Restless Sleep","RestEaze: A Novel Wearable Device and Mobile Application to Improve the Diagnosis and Management of Restless Sleep in Pediatric Patients With Attention Deficit\u002FHyperactivity Disorder, Phase II","Inclusion Criteria:\n\n* clinically diagnosed with ADHD\n* have blood ferritin level below 50ng\u002FmL\n* have parent- or self-reported restless sleep\n\nExclusion Criteria:\n\n* presence of any chronic medical or genetic condition that could impact iron metabolism\n* presence of moderate to severe Obstructive Sleep Apnea\n* having received Iron supplementation treatment within the past 3 months\n* having blood ferritin level indicative of anemia that requires immediate treatment","ALL","8 Years","18 Years",{"count":69,"type":70},70,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are:\n\nDoes 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and\u002For objectively measured attention more than placebo?\n\nResearchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD.\n\nParticipants will:\n\n* Take iron supplements every day for 3 months\n* Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention\n* Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment",[77,78],"ADHD","Sleep Problems",[77,80,81,82,83,84],"iron supplements","sleep","restlessness","attention","restless legs syndrome","NOT_YET_RECRUITING","2026-04-30",{"date":88,"type":89},"2026-05-04","ACTUAL",{"date":91,"type":70},"2027-03-01",{"date":93,"type":70},"2027-07-31",{"name":5,"class":6},1]