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Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)

RecruitingPhase 2Ages 18 Years - 65 YearsAllLagos State University
NCT07269457 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Traumatic 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. A 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: Group 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 + Pl

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 to 65 years * Diagnosed with mild-to-moderate TBI defined by GCS 9-15 * Presenting within 24 hours of head injury * Willing and able to provide informed consent or have a legal representative provide consent * Confirmed vitamin D-deficient status (\<30 ng/mL) for randomization into treatment arms OR Vitamin D-sufficient (≥30 ng/mL) to be eligible for inclusion in the observational control arm. Exclusion Criteria: * Severe TBI (GCS ≤8) * Prior use of vitamin D supplements within the past month * History of hypercalcemia or hyperparathyroidism * Pregnancy or lactation * Use of immunosuppressive agents (e.g., corticosteroids, cytotoxic drugs) * Chronic liver disease * End-stage renal disease * Any terminal illness or comorbidity with expected survival \<3 months
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What it tests

  • Vitamin D3 (Cholecalciferol)
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Where

1 site
Lagos State University Teaching Hospital
Lagos, Nigeria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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