Vitamin D3 for Moderate to Mild Traumatic Brain Injury: A Randomized Trial on Inflammation and Recovery (VIMOT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in C-reactive protein (CRP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group B (Deficient + Standard-Dose D₃)
2,000 IU daily for 3 weeks
干预措施: Vitamin D3 (Cholecalciferol) (Drug)
Group C (Sufficient + Standard-Dose D₃)
2,000 IU daily for 3 weeks
干预措施: Vitamin D3 (Cholecalciferol) (Drug)
Group A (Deficient + High-Dose D₃)
40,000 IU loading dose on day 1, followed by 4,000 IU daily for 3 weeks
干预措施: Vitamin D3 (Cholecalciferol) (Drug)
结局指标
主要结局
Change in C-reactive protein (CRP)
时间窗: 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.
次要结局
- 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)
- 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)
研究者
Olufemi Idowu
Principal Investigator,
Lagos State University