[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650716":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":17,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":17,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":40,"whyStopped":17,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo condition","PLACEBO_COMPARATOR","Magnesium tablet, 3 tablets a day dissolved in water, without active ingredient of molecular hydrogen. 16 week duration.",[13],"Dietary Supplement: Placebo condition",{"label":15,"type":16,"description":17,"interventionNames":18},"Active hydrogen water intervention","EXPERIMENTAL",null,[19],"Dietary Supplement: Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.",[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":17},"DIETARY_SUPPLEMENT","16 week intervention of magnesium pill without active ingredient of molecular hydrogen.",[9],{"type":22,"name":26,"description":27,"armGroupLabels":28,"otherNames":17},"Molecular hydrogen produced by a metallic magnesium tablet, consumed 3x a day dissolved in water. Treatment duration is 16 weeks.","The 3 daily doses of molecular hydrogen scheduled for a 16 week intervention. This distinguishes it from the placebo comparator condition.",[15],[30],{"name":31,"affiliation":5,"role":32},"Fred Friedberg, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":17,"email":37},"CONTACT","16316381931","Fred.Friedberg@stonybrookmedicine.edu",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Stony Brook","New York","11794-6000","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-73.14094,40.92565,{"lat":50,"lon":49},[53],{"name":31,"role":35,"phone":54,"phoneExt":17,"email":55},"5167024213","ffriedberg12@gmail.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SPONSOR_INVESTIGATOR","Fred Friedberg","Principal Investigator","100650716","controlled-trial-of-hydrogen-water-as-a-treatment-for-myalgic-encephalomyelitischronic-fatigue-syndrome-100650716",false,"NCT07753122","Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Randomized Controlled Trial of Moderate Dose Hydrogen Water as a Treatment for ME\u002FCFS","ME\u002FCFS","Inclusion Criteria:\n\n* Patients aged 18-65 of both sexes\n* considered physically capable and willing to perform the study tasks\n* Meet validated phone-screen eligibility for ME\u002FCFS criteria\n* Participant has internet and computer\n\nExclusion Criteria:\n\n* Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS. Kidney disease\u002Frenal failure is also an exclusion\n* Exclusionary psychiatric disorders include any psychosis, or alcohol\u002F substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME\u002FCFS or anytime afterward\n\n  * Pregnancy is an exclusion.\n\n    * Patients with BMI\\>35\n\n      \\_\\_\\_\\_Patients regularly taking therapeutic magnesium.\n    * Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.","ALL","18 Years","65 Years",{"count":72,"type":73},80,"ESTIMATED","INTERVENTIONAL",[76],"NA","This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME\u002FCFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME\u002FCFS observational study.",[79],"Chronic Fatigue Syndrome (CFS)",[81],"chronic fatigue syndrome; myalgic encephelomyelitis; ME\u002FCFS; hydrogen water; treatment; biomarker heart rate variability","2026-08-03",{"date":84,"type":85},"2026-08-07","ACTUAL",{"date":87,"type":73},"2026-08-15",{"date":89,"type":73},"2027-07",{"name":58,"class":6},1]