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

NCT07269457 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NHREC/LASUCOM-HREC/5/5/25
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Traumatic Brain Injury (TBI) Patients; Neuroinflammation

Keywords

Traumatic Brain Injury (TBI); Neuroinflammation; Vitamin D3; Glasgow Outcome Scale - Extended (GOS-E); Modified Rankin Scale (mRS); Sub-Saharan Africa

Outcome Measures

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.

  4 weeks

Secondary Outcomes (3)

• Change in inflammatory biomarkers (ESR, SIRI, SII, PLR, NLR)

  4 weeks

• Neurological functional recovery assessed by Glasgow Outcome Scale-Extended (GOS-E)

  Week 4, Week 12, and Week 24

• Neurological functional recovery assessed by Modified Rankin Scale (mRS)

  Baseline, Week 4, Week 12, and Week 24

Study Arms (4)

Group A (Deficient + High-Dose D₃)

EXPERIMENTAL

40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks

Drug: Vitamin D3 (Cholecalciferol)

Group B (Deficient + Standard-Dose D₃)

ACTIVE COMPARATOR

2,000 IU daily for 3 weeks

Drug: Vitamin D3 (Cholecalciferol)

Group C (Sufficient + Standard-Dose D₃)

EXPERIMENTAL

2,000 IU daily for 3 weeks

Drug: Vitamin D3 (Cholecalciferol)

Group D

NO INTERVENTION

Sufficient + Placebo

Interventions

Vitamin D3 (Cholecalciferol) DRUG

Participants who are vitamin D deficient (\<30 ng/mL) will receive oral cholecalciferol 2,000 IU daily for 3 weeks.

Group A (Deficient + High-Dose D₃); Group B (Deficient + Standard-Dose D₃); Group C (Sufficient + Standard-Dose D₃)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lagos State University: lead
• Lagos State University Teaching Hospital (LASUTH): collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic; Neuroinflammatory Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Olufemi E IDOwu, MBBS, FWACS

CONTACT

+2348023451369; oeidowu412@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Model Details: 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.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.