[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560810":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":34,"collaborators":36,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":20,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":20,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":20,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":20},{"fullName":5,"class":6},"Meta Healthcare Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liquid valine and liquid isoleucine administration","EXPERIMENTAL","Liquid valine given for 28 days, liquid isoleucine for 28 days",[13],"Dietary Supplement: Valine oral solution (50mg\u002Fml) and isoleucine oral solution (25mg\u002Fml)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Valine oral solution (50mg\u002Fml) and isoleucine oral solution (25mg\u002Fml)","Subjects will take valine oral solution (50mg\u002Fml) in place of usual powdered valine supplement for 28 days. Subjects will then take isoleucine oral solution (25mg\u002Fml) in place of their usual powdered isoleucine supplement for 28 days.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Anita MacDonald","Birmingham Children's Hospital, UK","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+44 1213338024","anita.macdonald@nhs.net",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Sharon Evans","sharon.morris6@nhs.net",{"type":35,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[37],{"name":38,"class":39},"Birmingham Women's and Children's NHS Foundation Trust","OTHER","100560810","liquid-valine-and-isoleucine-in-maple-syrup-urine-disease-100560810",false,"NCT06581991","Liquid Valine and Isoleucine in Maple Syrup Urine Disease","Valine 50mg\u002Fml and Isoleucine 25mg\u002Fml Oral Solutions for Maple Syrup Urine Disease (MSUD) - Acceptability and Tolerance Study","Inclusion Criteria:\n\n* Male and female MSUD patients ≥1 year and \\\u003C16 years of age.\n* Patients diagnosed with MSUD.\n* Taking both valine and isoleucine supplements for MSUD and willing to take the new supplements for 56 days.\n* Absence of comorbidities.\n* Adherence with dietary management and valine and isoleucine supplements.\n* Able to understand and comply with the requirements of the investigation and sign the Informed Consent Form\u002FAssent form\n\nExclusion Criteria:\n\n* Age \\\u003C1 year old and \\>16 years old.\n* Patients with comorbidities.\n* Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome.\n* History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures.\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.","ALL","12 Months","16 Years",{"count":51,"type":52},5,"ESTIMATED","INTERVENTIONAL",[55],"NA","This is a prospective, observational research study in 5 children with Maple Syrup Urine Disease (MSUD). Subjects who are currently taking a valine and isoleucine supplement for MSUD will be recruited for a 56 day trial, of a new ready-to-use valine supplement and a new ready-to-use isoleucine supplement, to evaluate the tolerability and acceptability of the study products compared with their usual products.",[58],"Maple Syrup Urine Disease",[58,60,61,62],"MSUD","Valine","Isoleucine","NOT_YET_RECRUITING","2024-08-29",{"date":66,"type":67},"2024-09-03","ACTUAL",{"date":69,"type":52},"2024-10",{"date":71,"type":52},"2026-09",{"name":5,"class":6}]