[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589810":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":84,"collaborators":33,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":33,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":33,"enrollmentInfo":96,"targetDuration":33,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":55,"whyStopped":33,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Instituto Nacional de Enfermedades Respiratorias","OTHER_GOV",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Glycine","EXPERIMENTAL","Patients will receive for 6 months an oral supplement of 0.5 g\u002Fkg\u002Fday glycine, up to 25 g\u002Fday, divided in three daily intakes.",[13],"Dietary Supplement: Glycine",{"label":15,"type":10,"description":16,"interventionNames":17},"Magnesium+thiamine","Patients will receive for 6 months an oral supplement of up to 400 mg\u002Fday, according to age, of elementary magnesium (formulated as magnesium citrate) plus up to 10 mg\u002Fday of thiamine (formulated as benfotiamine), divided in three daily intakes.",[18],"Dietary Supplement: Magnesium+thiamine",{"label":20,"type":10,"description":21,"interventionNames":22},"Glycine plus magnesium+thiamine","Patients will receive for 6 months oral supplements of glycine and magnesium+thiamine, as described.",[13,18],{"label":24,"type":25,"description":26,"interventionNames":27},"Placebo","PLACEBO_COMPARATOR","Patients will receive for 6 months placebo (sugar glass), in a similar daily amount as in experimental arms, and divided in three daily intakes.",[28],"Other: Placebo",[30,34,36],{"type":31,"name":9,"description":11,"armGroupLabels":32,"otherNames":33},"DIETARY_SUPPLEMENT",[9,20],null,{"type":31,"name":15,"description":16,"armGroupLabels":35,"otherNames":33},[20,15],{"type":37,"name":24,"description":26,"armGroupLabels":38,"otherNames":33},"OTHER",[24],[40],{"name":41,"affiliation":42,"role":43},"Mario H. Vargas, MSc","5556665868","PRINCIPAL_INVESTIGATOR",[45,48],{"name":41,"role":46,"phone":42,"phoneExt":33,"email":47},"CONTACT","mhvargasb@yahoo.com.mx",{"name":49,"role":46,"phone":50,"phoneExt":51,"email":52},"Mario A. Flores-Valadez, MD","5554871700","5160","mario.flores.valadez@gmail.com",[54],{"facility":5,"status":55,"city":56,"state":33,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"RECRUITING","Mexico City","14080","Mexico","MX",{"type":61,"coordinates":62},"Point",[63,64],-99.12766,19.42847,{"lat":64,"lon":63},[67,68,70,72,74,76,78,80,82],{"name":41,"role":46,"phone":42,"phoneExt":33,"email":47},{"name":69,"role":43,"phone":33,"phoneExt":33,"email":33},"Mario H. Vargas, MD, MSc",{"name":49,"role":71,"phone":33,"phoneExt":33,"email":33},"SUB_INVESTIGATOR",{"name":73,"role":71,"phone":33,"phoneExt":33,"email":33},"Rosangela Del Razo, MD, MSc",{"name":75,"role":71,"phone":33,"phoneExt":33,"email":33},"Jaime Chávez-Alderete, PhD",{"name":77,"role":71,"phone":33,"phoneExt":33,"email":33},"Laura G. Gochicoa-Rangel, PhD",{"name":79,"role":71,"phone":33,"phoneExt":33,"email":33},"Fernanda A. Bañuelos-Macías, MD",{"name":81,"role":71,"phone":33,"phoneExt":33,"email":33},"Juan C. León-Contreras, MD",{"name":83,"role":71,"phone":33,"phoneExt":33,"email":33},"Ericka S. Peña-Mirabal, MD",{"type":43,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Mario H. Vargas","Senior Researcher","100589810","glycine-and-magnesiumthiamine-for-the-treatment-of-primary-ciliary-dyskinesia-100589810",false,"NCT06959251","Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia","A Randomized, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of Glycine and Magnesium+Thiamine Supplements, Alone or Combined, Administered for 6 Months to Patients With Primary Ciliary Dyskinesia","Inclusion Criteria:\n\n1. Any sex.\n2. Age of 5 years or more.\n3. Diagnosis of primary ciliary dyskinesia (PCD) established according to international recommendations (Shapiro et al. Am J Respir Crit Care Med 2018;197(12):e24-e39, and Shapiro et al. Ped Pulmonol 2016;51:115-132).\n4. Without respiratory exacerbations of PCD in the previous 30 days.\n5. Without acute respiratory infection in the previous 30 days.\n6. Informed consent letter signed by the patient (if the patient's age is 18 years or more).\n7. Informed consent letter signed by the legal guardian, and assent letter signed by the patient (if the patient's age is \\\u003C18 years).\n\nExclusion Criteria:\n\n1\\. Participation in other research protocol involving therapeutic measures.\n\nElimination Criteria:\n\n1\\. None.","ALL","5 Years",{"count":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"NA","* Patients with primary ciliary dyskinesia (PCD) have trouble with clearing their bronchi from mucus, which in the long-term may produce severe damage to the lungs. Currently, there is no specific treatment for PCD beyond supportive measures such as airway hydration and postural drainage.\n* Glycine is an amino acid with anti-inflammatory properties that proved to be beneficial in another disease with problematic airway clearance, cystic fibrosis.\n* Magnesium participates in many crucial chemical reactions, including some that might favor fluidification and mobilization of mucus. Thiamine (vitamin B1) co-participates with magnesium in some mitochondrial enzymatic reactions occurring in the citric acid cycle.\n* Thus, oral supplements of glycine and magnesium+thiamine might improve symptoms and lung function of patients with PCD, and these effects may even be better if these supplements are combined.\n* In this study, in addition to their usual care, patients with PCD will receive for 6 months one of the following treatments: 1) an oral supplement of 0.5 g\u002Fkg\u002Fday glycine, 2) an oral supplement of up to 400 mg\u002Fday elementary magnesium plus up to 10 mg\u002Fday thiamine, according to the subject's age, 3) glycine plus magnesium+thiamine supplements, as described, or 4) a placebo, which is an inert substance. All treatments will be administered as a whitish powder contained in similar bottles.\n* The investigators will evaluate whether glycine and\u002For magnesium+thiamine reduce exacerbations of the disease, improve pulmonary function and quality of life, and reduce some pro-inflammatory compounds measured in saliva.",[104],"Primary Ciliary Dyskinesia",[106,9,107,108,109,110],"Primary ciliary dyskinesia","Magnesium","Lung function","thiamine","benfotiamine","2025-11-20",{"date":113,"type":114},"2025-11-25","ACTUAL",{"date":116,"type":114},"2025-10-02",{"date":118,"type":98},"2028-03",{"name":5,"class":6},1]