Creatine Supplementation in Pediatric Brain Injury

N/ANot Yet RecruitingNCT07756060

Spaulding Rehabilitation Hospital46 enrolled

Overview

A study examining the effects of creatine supplementation to improve recovery after brain injury in children and teenagers.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Brain Injury Traumatic Brain Injury Stroke

Interventions

Creatine monohydrateDIETARY_SUPPLEMENT

12 weeks of creating monohydrate supplementation at 5 gm, twice per day

Microcrystalline CelluloseOTHER

Microcrystalline cellulose, which is an inert powder that is indistinguishable from creatine monohydrate in all sensory and procedural aspects, including appearance, taste, and solvability

Eligibility

Sex: ALLMin age: 8 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recruitment rate

Proportion of subjects who enroll in the study compared to those who are approached for consent

Time frame: 12 weeks

Attrition

Proportion of subjects who consent for study participation and exit from the study prior to completing 12 weeks of supplementation

Time frame: 12 weeks

Retention

Proportion of subjects who enroll in the study and subsequently complete 12 weeks of supplementation.

Time frame: 12 weeks

Dosing adherence

Proportion of prescribed supplement doses which are recorded to be taken across 12 weeks of supplementation.

Time frame: 12 weeks

Secondary Outcomes

Creatinine

Serum based marker of kidney function, commonly checked as part of a standard basic metabolic panel in outpatient and inpatient medical settings. Normal range is 0.3-1.59 mg/dL depending on age and gender.

Time frame: 12 weeks

Cystatin C

Small protein filtered nearly entirely by kidney and can be measured in blood serum levels as a marker of kidney function. Healthy reference range is 0.6-1.0 mg/L.

Time frame: 12 weeks

Extended Glasgow Outcome Scale

Clinical scale used to assess overall functional outcome after traumatic brain injury. Ranges 1-8 with higher scores reflecting better recovery.

Time frame: 12 months

Data from ClinicalTrials.gov

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