Traumatic Brain Injury (TBI) PatientsPhase 2VIMOTNCT07269457
Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)
A Phase 2 study testing Vitamin D3 (Cholecalciferol) in people with Traumatic Brain Injury (TBI) Patients and Neuroinflammation, run by Lagos State University at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Neuroinflammation
- What is being tested?
- Vitamin D3 (Cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Mar 2026to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria1 site, 1 recruiting
- Recruiting
Lagos State University Teaching Hospital
Lagos
Olufemi Idowu, MBBS, FWACS, 2348023451369, oeidowu412@yahoo.com
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Vitamin D3 (Cholecalciferol)
- Keywords
- Traumatic Brain Injury (TBI), Neuroinflammation, Vitamin D3, Glasgow Outcome Scale - Extended (GOS-E), Modified Rankin Scale (mRS), Sub-Saharan Africa
- Medical subject headings
- Brain Injuries, Traumatic, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Cholecalciferol)Drug
Participants who are vitamin D deficient (<30 ng/mL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Deficient + High-Dose D₃) | Experimental | 40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks Receives: Drug: Vitamin D3 (Cholecalciferol) |
| Group B (Deficient + Standard-Dose D₃) | Active comparator | 2,000 IU daily for 3 weeks Receives: Drug: Vitamin D3 (Cholecalciferol) |
| Group C (Sufficient + Standard-Dose D₃) | Experimental | 2,000 IU daily for 3 weeks Receives: Drug: Vitamin D3 (Cholecalciferol) |
| Group D | No intervention | Sufficient + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Baseline, Week 4, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start2 Mar 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a Phase II, four-arm, parallel-group, randomized, quadruple-blinded, placebo-controlled interventional model designed to evaluate the efficacy and safety of high-dose versus standard-dose vitamin D₃ supplementation in adults with mild-to-moderate traumatic brain injury (TBI). Participants will be stratified by baseline vitamin D status (deficient or sufficient) and randomized into one of four parallel treatment arms. Each group will receive its assigned intervention for three weeks, followed by a 24-week follow-up period. Randomization will be computer-generated using permuted block design to ensure balance, and allocation will be concealed through sequentially numbered opaque envelopes. Blinding will include participants, caregivers, investigators, and outcome assessors.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olufemi Idowu, Lagos State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269457
- Sponsor's protocol ID
- LASUCOM-HREC: CM/HREC.182/017B
- Acronym
- VIMOT
- Status last verified
- May 2026
- First submitted
- 25 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)
- ClinicalTrials.gov ID
- NCT07269457
- Acronym / sponsor ID
- VIMOT / LASUCOM-HREC: CM/HREC.182/017B
- Keywords
- Traumatic Brain Injury (TBI), Neuroinflammation, Vitamin D3, Glasgow Outcome Scale - Extended (GOS-E), Modified Rankin Scale (mRS), Sub-Saharan Africa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study adopts a Phase II, four-arm, parallel-group, randomized, quadruple-blinded, placebo-controlled interventional model designed to evaluate the efficacy and safety of high-dose versus standard-dose vitamin D₃ supplementation in adults with mild-to-moderate traumatic brain injury (TBI). Participants will be stratified by baseline vitamin D status (deficient or sufficient) and randomized into one of four parallel treatment arms. Each group will receive its assigned intervention for three weeks, followed by a 24-week follow-up period. Randomization will be computer-generated using permuted block design to ensure balance, and allocation will be concealed through sequentially numbered opaque envelopes. Blinding will include participants, caregivers, investigators, and outcome assessors.
| Arm | Type | Receives |
|---|---|---|
| Group A (Deficient + High-Dose D₃) | Experimental | Drug: Vitamin D3 (Cholecalciferol)40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks |
| Group B (Deficient + Standard-Dose D₃) | Active comparator | Drug: Vitamin D3 (Cholecalciferol)2,000 IU daily for 3 weeks |
| Group C (Sufficient + Standard-Dose D₃) | Experimental | Drug: Vitamin D3 (Cholecalciferol)2,000 IU daily for 3 weeks |
| Group D | No intervention | –Sufficient + Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (Cholecalciferol)Participants who are vitamin D deficient (<30 ng/mL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks. | Drug | Group A (Deficient + High-Dose D₃), Group B (Deficient + Standard-Dose D₃), Group C (Sufficient + Standard-Dose D₃) |
Primary outcome
Change in C-reactive protein (CRP)
Time frame: 4 weeks
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.
3 secondary outcomes
Change in inflammatory biomarkers (ESR, SIRI, SII, PLR, NLR)
Time frame: 4 weeks
Neurological functional recovery assessed by Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Week 4, Week 12, and Week 24
Neurological functional recovery assessed by Modified Rankin Scale (mRS)
Time frame: Baseline, Week 4, Week 12, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 (Cholecalciferol) in people with Traumatic Brain Injury (TBI) Patients and Neuroinflammation, run by Lagos State University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olufemi E IDOwu, MBBS, FWACS (+2348023451369, oeidowu412@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in C-reactive protein (CRP) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.