RecruitingPhase 2

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

Nigeria240 participantsStarted 2026-03-02

Plain-language summary

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 + 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). The main outcomes are changes in inflammatory markers. Secondary outcomes include mortality, functional recovery, hospital stay, safety, and cost-effectiveness. The results may identify a low-cost, scalable treatment to improve outcomes after TBI, especially in low-resource settings.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in C-reactive protein (CRP)

Timeframe: 4 weeks

Trial details

NCT IDNCT07269457

SponsorLagos State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Olufemi E IDOwu, MBBS, FWACS

+2348023451369 oeidowu412@yahoo.com

View on ClinicalTrials.gov More Traumatic Brain Injury (TBI) Patients trials