[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Independent Medical Alliance\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100590439","phase-2-effect-of-metabolic-modulation-on-a-post-acute-covid-19-vaccination-syndrome-pacvs-cohort-100590439",false,"NCT06967428","Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort","Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study","ViTAL-SCAN19","Inclusion Criteria:\n\n* Persistent fatigue lasting more than 6 months\n* Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)\n* Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.\n\nExclusion Criteria:\n\n* Pregnant\n* History of Schizophrenia\n* Currently using antidepressant medication","ALL","16 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.\n\nThe main questions it aims to answer are:\n\nDoes the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?\n\nDoes the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?\n\nResearchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.\n\nParticipants will:\n\nTake the assigned supplement daily for 3 months (ViTAL SCAN or placebo)\n\nAttend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring\n\nComplete quality of life and health behavior questionnaires\n\nUndergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)\n\nRecord supplement intake\n\nThis study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.",[27,28],"Vaccine Adverse Reaction","Post Acute Covid-19 Vaccination Syndrome",[28,30,31],"Metabolic Modulation","Amino Acids","NOT_YET_RECRUITING","2025-05-05",{"date":35,"type":36},"2025-05-13","ACTUAL",{"date":38,"type":21},"2025-09-01",{"date":40,"type":21},"2026-01",{"name":42,"class":43},"Independent Medical Alliance","OTHER",""]