[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613658":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":26,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":59,"id":63,"slug":26,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Lagos State University","OTHER",[8,14,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (Deficient + High-Dose D₃)","EXPERIMENTAL","40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks",[13],"Drug: Vitamin D3 (Cholecalciferol)",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B (Deficient + Standard-Dose D₃)","ACTIVE_COMPARATOR","2,000 IU daily for 3 weeks",[13],{"label":20,"type":10,"description":17,"interventionNames":21},"Group C (Sufficient + Standard-Dose D₃)",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Group D","NO_INTERVENTION","Sufficient + Placebo",null,[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":26},"DRUG","Vitamin D3 (Cholecalciferol)","Participants who are vitamin D deficient (\\\u003C30 ng\u002FmL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks.",[9,15,20],[34],{"name":35,"role":36,"phone":37,"phoneExt":26,"email":38},"Olufemi E IDOwu, MBBS, FWACS","CONTACT","+2348023451369","oeidowu412@yahoo.com",[40],{"facility":41,"status":42,"city":43,"state":26,"zip":26,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Lagos State University Teaching Hospital","RECRUITING","Lagos","Nigeria",{"type":46,"coordinates":47},"Point",[48,49],3.39467,6.45407,{"lat":49,"lon":48},[52],{"name":53,"role":36,"phone":54,"phoneExt":26,"email":38},"Olufemi Idowu, MBBS, FWACS","2348023451369",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Olufemi Idowu","Principal Investigator,",[60],{"name":61,"class":62},"Lagos State University Teaching Hospital (LASUTH)","UNKNOWN","100613658",false,"NCT07269457","Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)","VIMOT","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Diagnosed with mild-to-moderate TBI defined by GCS 9-15\n* Presenting within 24 hours of head injury\n* Willing and able to provide informed consent or have a legal representative provide consent\n* Confirmed vitamin D-deficient status (\\\u003C30 ng\u002FmL) for randomization into treatment arms OR Vitamin D-sufficient (≥30 ng\u002FmL) to be eligible for inclusion in the observational control arm.\n\nExclusion Criteria:\n\n* Severe TBI (GCS ≤8)\n* Prior use of vitamin D supplements within the past month\n* History of hypercalcemia or hyperparathyroidism\n* Pregnancy or lactation\n* Use of immunosuppressive agents (e.g., corticosteroids, cytotoxic drugs)\n* Chronic liver disease\n* End-stage renal disease\n* Any terminal illness or comorbidity with expected survival \\\u003C3 months","ALL","18 Years","65 Years",{"count":73,"type":74},240,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This study is a Phase II, randomized, quadruple-blinded, placebo-controlled clinical trial designed to test whether vitamin D₃ supplementation can improve recovery after mild-to-moderate traumatic brain injury (TBI) in adults.\n\nTraumatic brain injury often leads to inflammation and poor neurological outcomes, and many patients are vitamin D-deficient. Vitamin D₃ is a safe, widely available supplement that may reduce inflammation and support brain recovery.\n\nA total of 240 adults (18-65 years) with mild-to-moderate TBI will be enrolled at Lagos State University Teaching Hospital, Nigeria. Participants will be assigned to one of four groups:\n\nGroup A (Deficient + High-Dose D₃): 40,000 IU loading dose, then 4,000 IU daily for 3 weeks Group B (Deficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group C (Sufficient + Standard-Dose D₃): 2,000 IU daily for 3 weeks Group D (Sufficient + Placebo): placebo daily for 3 weeks All groups will be followed for 24 weeks. Blood tests at baseline, week 1, week 2, and week 4 will measure inflammation. Neurological recovery will be assessed at weeks 4, 12, and 24 using the Glasgow Outcome Scale-Extended (GOS-E) and Modified Rankin Scale (mRS).\n\nThe main outcomes are changes in inflammatory markers. Secondary outcomes include mortality, functional recovery, hospital stay, safety, and cost-effectiveness.\n\nThe results may identify a low-cost, scalable treatment to improve outcomes after TBI, especially in low-resource settings.",[80,81],"Traumatic Brain Injury (TBI) Patients","Neuroinflammation",[83,81,84,85,86,87],"Traumatic Brain Injury (TBI)","Vitamin D3","Glasgow Outcome Scale - Extended (GOS-E)","Modified Rankin Scale (mRS)","Sub-Saharan Africa","2026-05-08",{"date":90,"type":91},"2026-05-13","ACTUAL",{"date":93,"type":91},"2026-03-02",{"date":95,"type":74},"2028-12-30",{"name":5,"class":6},1]