[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385661":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":50,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Vitae Health Innovation","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ImmunoVita®","ACTIVE_COMPARATOR","250 mg Yeast beta-glucan + 3.75 microg Vitamin D3 + 1.05 mg Vitamin B6 + 7.5 mg zinc)",[13],"Dietary Supplement: Active",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","473,2 mg microcristalline cellulose + 0,06 mg Brown Oxide dye + 0,27 mg yellow A oxide dye",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Active","Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).",[9],[9],{"type":22,"name":15,"description":24,"armGroupLabels":28,"otherNames":29},[15],null,[31],{"name":32,"affiliation":33,"role":34},"José Alegre, PhD","Hospital Vall d´Hebron","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":29,"city":38,"state":29,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":29},"Hospital Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],2.15899,41.38879,{"lat":46,"lon":45},{"type":49,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[51],{"name":37,"class":52},"OTHER","100385661","clinical-trial-to-assess-the-improvement-of-fatigue-sleep-problems-anxiety--depression-neurovegetatives-alterations-and-quality-of-life-after-the-administration-of-immunovita-in-chronic-fatigue-syndrome-patients-100385661",false,"NCT04301609","Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety \u002F Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients","Randomized, Comparative, Double-blind, and Placebo-controlled Clinical Trial to Assess the Improvement of Fatigue, Sleep, Anxiety \u002F Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients","Inclusion Criteria:\n\n* Adult patients of both sexes, between 18-65 years.\n* Patients with a BMI ≤ 25.\n* Patients diagnosed with Chronic Fatigue Syndrome according to diagnostic criteria of 1994 CDC \u002F Fukuda and 2003 Canadian criteria from the University of Central Sensitization Syndrome (Vall d'Hebron University Hospital, Barcelona).\n* Patients who freely grant written consent.\n\nExclusion Criteria:\n\n* Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.\n* Any subject that, in the opinion of the investigator, is not able to follow the instructions or make a good completion of the treatment.\n* Subjects who do not grant written informed consent to participate in the study.\n* Patients who are receiving any of the prohibited drugs or products and that the withdrawal of the drugs \u002F products not allowed in the study is expected to pose a relevant problem.\n* Pregnant women and \u002F or during breastfeeding periods.\n* Patients under treatment with oral anticoagulants.\n* Patient with any type of immunosuppression.","ALL","18 Years","65 Years",{"count":64,"type":65},67,"ACTUAL","INTERVENTIONAL",[68],"NA","Chronic Fatigue Syndrome, also known as Myalgic Encephalomyelitis (CFS \u002F MS) is a medical entity characterized mainly by debilitating and prolonged fatigue lasting more than 6 months, post-exertion fatigue (physical and \u002F or mental), non-sleep restorative, cognitive impairment and orthostatic intolerance with prolonged recovery that is not relieved by rest. Currently, the etiopathogenic mechanisms of the disease are not known, although mitochondrial dysfunction with bioenergetic immuno-metabolism alterations, oxidative stress, and immuno-inflammatory response stands out. At present, there is no diagnostic test, nor effective treatment in the disease. ImmunoVita, is a food supplement composed of the latest yeast beta-glucans, in addition to vitamin D3, vitamin B6 and zinc, which could contribute to the normal functioning of the immune system and the inflammatory response.",[71,72],"Chronic Fatigue Syndrome","Myalgic Encephalomyelitis",[74,75,76],"Fatigue Syndrome","Encephalomyelitis","Fibromyalgia","COMPLETED","2023-03-13",{"date":80,"type":65},"2023-03-15",{"date":82,"type":65},"2021-11-10",{"date":84,"type":65},"2023-01-31",{"name":5,"class":6},1]