Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLagos State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe TBI (GCS ≤8)
Prior use of vitamin D supplements within the past month
History of hypercalcemia or hyperparathyroidism
Pregnancy or lactation
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin D3 (Cholecalciferol)
DrugParticipants who are vitamin D deficient (\<30 ng/mL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Group A (Deficient + High-Dose D₃)Experimental treatment 1 intervention
Group B: Group B (Deficient + Standard-Dose D₃)Active comparator 1 intervention
Group C: Group C (Sufficient + Standard-Dose D₃)Experimental treatment 1 intervention
Group D: Group DNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 243
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 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lagos State University
Lead sponsor
Lagos State University Teaching Hospital (LASUTH)
Collaborator
Source ClinicalTrials.gov