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

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-12-30

Summary

This study is a Phase II, randomized, quadruple-blinded, placebo-controlled clinical trial designed to test whether vitamin D 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 D 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 D): 40,000 IU loading dose, then 4,000 IU daily for 3 weeks Group B (Deficient + Standard-Dose D): 2,000 IU daily for 3 weeks Group C (Sufficient + Standard-Dose D): 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.

• Phase: PHASE2

Details

• Lead Sponsor: Lagos State University
• Collaborator: Lagos State University Teaching Hospital (LASUTH)
• Treatments: Cholecalciferol