Vitamin D3 to help recovery after mild-to-moderate traumatic brain injury
Official title: Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)
Run by Lagos State University · NCT07269457 · Data updated 2026-11-12
This trial will test whether a short course of vitamin D3 helps adults (18–65) recover better and reduce inflammation after mild-to-moderate traumatic brain injury.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Lagos State University Academic / other |
| Locations | 1 site (Lagos) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | December 30, 2028 |
| Study ends | December 30, 2028 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07269457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 presenting within 24 hours of a mild-to-moderate TBI (GCS 9–15) who can consent and do not have contraindications such as recent vitamin D use, hypercalcemia, severe liver or kidney disease, or pregnancy are ideal candidates.
✕Probably not a fit
People with severe TBI (GCS ≤8), recent vitamin D supplementation, pregnancy or lactation, hypercalcemia/hyperparathyroidism, end-stage renal disease, chronic liver disease, or those on immunosuppressive drugs are unlikely to be eligible or to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase II, randomized, quadruple-blinded, placebo-controlled trial will enroll 240 adults with mild-to-moderate TBI at Lagos State University Teaching Hospital. Participants will be stratified by baseline vitamin D status and randomized into four arms receiving either a high-dose loading plus daily cholecalciferol, standard-dose cholecalciferol, or placebo for three weeks. Outcomes include blood markers of inflammation and functional recovery measures such as the Glasgow Outcome Scale–Extended and the modified Rankin Scale, with safety monitoring and follow-up to 24 weeks. The design tests both correction of deficiency and dose effects in a low- and middle-income country setting.
Why it matters
Potential benefit: If successful, this could offer an inexpensive, widely available way to reduce brain inflammation and improve functional recovery after TBI.
How similar studies have gone: Preclinical and observational data suggest vitamin D has anti-inflammatory and neuroprotective effects, but randomized trials of vitamin D for TBI—particularly in LMIC settings—are limited or absent.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Lagos State University Teaching Hospital
Lagos, Nigeria Recruiting
Study contacts
- Study coordinator: Olufemi E IDOwu, MBBS, FWACS
- Email: oeidowu412@yahoo.com
- Phone: +2348023451369
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.