[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lagos State University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"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":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Traumatic Brain Injury (TBI) Patients","Neuroinflammation",[29,27,30,31,32,33],"Traumatic Brain Injury (TBI)","Vitamin D3","Glasgow Outcome Scale - Extended (GOS-E)","Modified Rankin Scale (mRS)","Sub-Saharan Africa","RECRUITING","2026-05-08",{"date":37,"type":38},"2026-05-13","ACTUAL",{"date":40,"type":38},"2026-03-02",{"date":42,"type":20},"2028-12-30",{"name":44,"class":45},"Lagos State University","OTHER",""]