A Phase 2 interventional study of Vitamin D3 (Cholecalciferol) in Traumatic Brain Injury (TBI) Patients and Neuroinflammation, sponsored by Lagos State University. Recruiting at 1 site in Nigeria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Lagos State University · Phase 2, Interventional, and Treatment
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.
Traumatic brain injury (TBI) is a leading cause of death and disability globally, with the majority of cases occurring in low- and middle-income countries (LMICs). Secondary brain injury, driven by inflammation, oxidative stress, and neurovascular disruption, is a major determinant of long-term disability. Despite this burden, there are no approved pharmacological therapies targeting the secondary injury cascade. Vitamin D₃ (cholecalciferol), a fat-soluble secosteroid hormone precursor, has immunomodulatory and neuroprotective properties, including suppression of pro-inflammatory cytokines (e.g., TNF-α, IL-6), enhancement of antioxidant defenses, and stabilization of the blood-brain barrier. However, its therapeutic potential in TBI has not been evaluated in randomized trials in LMICs.
This Phase II, four-arm, randomized, quadruple-blinded, placebo-controlled trial will evaluate the efficacy and safety of vitamin D₃ supplementation in adults (18-65 years) with mild-to-moderate TBI. A total of 240 participants will be stratified by vitamin D status at baseline and allocated into one of four groups:
Group A (Deficient + High-Dose D₃): 50,000 IU loading dose on day 1, followed by 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.
The intervention period is 3 weeks, with follow-up to 24 weeks. Randomization will use stratified block design (age, sex, GCS), and blinding will apply to participants, care providers, investigators, and outcome assessors.
Primary endpoints are changes in inflammatory biomarkers (CRP, ESR, SIRI, SII, PLR, NLR) and functional outcomes measured by the Glasgow Outcome Scale-Extended (GOS-E) and Modified Rankin Scale (mRS). Secondary endpoints include all-cause mortality at 28 days and 24 weeks, hospital length of stay, adverse events (e.g., hypercalcemia), and cost-effectiveness expressed as incremental cost-effectiveness ratios (ICERs) per DALY and QALY averted.
Safety monitoring will include weekly serum calcium and renal function tests during supplementation, adverse event documentation, and oversight by an independent Data Safety Monitoring Board (DSMB). The study will be conducted under Good Clinical Practice (GCP) standards, with regulatory approval and institutional ethics board approval.
This trial is designed to generate context-specific, clinically actionable evidence on whether vitamin D₃ supplementation improves recovery following TBI. If effective, the intervention is highly scalable given its low cost, wide availability, and favorable safety profile, with potential integration into national TBI management guidelines in LMICs.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 240 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Lagos State University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks
Drug: Vitamin D3 (Cholecalciferol)
2,000 IU daily for 3 weeks
Drug: Vitamin D3 (Cholecalciferol)
2,000 IU daily for 3 weeks
Drug: Vitamin D3 (Cholecalciferol)
Sufficient + Placebo
Participants who are vitamin D deficient (\<30 ng/mL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks.
Change in C-reactive protein (CRP)
Serum levels of CRP in all patients will be measured at baseline, Weeks 1, 2, and 4. The primary analysis will assess the mean percentage reduction in markers between baseline and Week 4 across study arms.
Time frame: 4 weeks
Change in inflammatory biomarkers (ESR, SIRI, SII, PLR, NLR)
Serum levels of ESR, SIRI, SII, PLR, NLR in all patients will be measured at baseline, Weeks 1, 2, and 4. The primary analysis will assess the mean percentage reduction in markers between baseline and Week 4 across study arms.
Time frame: 4 weeks
Neurological functional recovery assessed by Glasgow Outcome Scale-Extended (GOS-E)
All patients, functional outcome will be measured using structured GOS-E interviews, scored by blinded assessors. Improvement defined as ≥1 category increase from baseline
Time frame: Week 4, Week 12, and Week 24
Neurological functional recovery assessed by Modified Rankin Scale (mRS)
Disability level of all patients will be assessed with the Rankin Focused Assessment method for mRS. Improvement defined as ≥1 grade reduction compared to baseline
Time frame: Baseline, Week 4, Week 12, and Week 24
Plan to share: Yes — The following de-identified individual participant data (IPD) will be shared: Baseline demographics (age, sex, socioeconomic status, education level). Clinical characteristics at admission (Glasgow Coma Scale score, time from injury to presentation, comorbidities). Laboratory results (serum 25(OH)D levels, calcium, creatinine, CRP, ESR, and other inflammatory markers such as SIRI, SII, PLR, NLR). Intervention assignment (treatment arm) and dosing adherence. Neurological outcome measures (Glasgow Outcome Scale-Extended [GOS-E], Modified Rankin Scale [mRS]) at Weeks 4, 12, and 24. Clinical outcomes (length of hospital stay, complications, 28-day mortality, 12-week mortality). Adverse events and serious adverse events, including severity and relatedness to intervention. Cost-related outcomes (hospitalization cost, laboratory investigations, and other direct medical costs).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD and supporting information will be available starting 6 months after publication of the primary manuscript and will remain available for 5 years
Access criteria: Qualified investigators engaged in scientific research with a methodologically sound proposal. De-identified individual participant data, study protocol, statistical analysis plan, and analytic code. Requests should be submitted via email to the Principal Investigator (PI). Upon approval of a data use agreement, data will be transferred securely.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2028, 33 months after the start.
Of 46 phase 2 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 30. This study's planned 33 months is below that.
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Studies of the drug tested here: Cholecalciferol
Lagos State University