Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 46
- Primary Endpoint
- Recruitment rate
Study Overview
Brief Summary
A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control
Intervention: Microcrystalline Cellulose (Other)
Creatine
Intervention: Creatine monohydrate (Dietary Supplement)
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: 12 weeks
Proportion of subjects who enroll in the study compared to those who are approached for consent
Attrition
Time Frame: 12 weeks
Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation
Retention
Time Frame: 12 weeks
Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation.
Dosing adherence
Time Frame: 12 weeks
Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation.
Secondary Outcomes
- Creatinine(12 weeks)
- Cystatin C(12 weeks)
- Extended Glasgow Outcome Scale(12 months)
- Interhemispheric coherence(12 months)
- Cerebral blood flow velocity(12 months)
Investigators
Jennifer C, Wu
Clinician Investigator
Spaulding Rehabilitation Hospital