Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- Recruitment rate
研究概览
简要总结
A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.
详细描述
A 12-week creatine vs placebo supplementation trial in pediatric patients admitted to inpatient rehabilitation with new functional impairments due to brain injury. Effects will be monitored with labs, electroencephalography, transcranial doppler ultrasonography, and clinical assessment.
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
- 8 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of subacute moderate-to-severe brain injury resulting in a new functional impairment, as defined by: Glasgow Coma Scale score (GCS) < 13 points
- •Subacute brain injury is defined to be < 3 months since index injury
排除标准
- •Weight < 25 kg
- •History pre-existing chronic kidney disease (CKD stage ≥ 2), prior kidney transplantation, previous dialysis dependence, or solitary kidney status
- •Premorbid (pre-brain injury) eGFR < 60
- •Inability to obtain regular phlebotomy for any reason
- •Known inborn errors of mitochondrial function
- •Premorbid history of significant head trauma or brain injury requiring hospitalization
- •Pregnancy
- •Concurrent malignancy
- •Any other current, serious, chronic medical or psychiatric disease that in the PI's judgment may interfere with study participation or data integrity
研究组 & 干预措施
Control
干预措施: Microcrystalline Cellulose (Other)
Creatine
干预措施: Creatine monohydrate (Dietary Supplement)
结局指标
主要结局
Recruitment rate
时间窗: 12 weeks
Proportion of subjects who enroll in the study compared to those who are approached for consent
Attrition
时间窗: 12 weeks
Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation
Retention
时间窗: 12 weeks
Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation.
Dosing adherence
时间窗: 12 weeks
Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation.
次要结局
- Creatinine(12 weeks)
- Cystatin C(12 weeks)
- Extended Glasgow Outcome Scale(12 months)
- Interhemispheric coherence(12 months)
- Cerebral blood flow velocity(12 months)
研究者
Jennifer C, Wu
Clinician Investigator
Spaulding Rehabilitation Hospital