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NCT Number: NCT07756060

Creatine Supplementation in Pediatric Brain Injury

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

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Key information

Conditions

Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

8 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

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

Microcrystalline Cellulose

Other

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

Primary outcomes

  1. Recruitment rate

    Time frame: 12 weeks

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

  2. 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

  3. Retention

    Time frame: 12 weeks

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

  4. Dosing adherence

    Time frame: 12 weeks

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

Secondary outcomes

  1. Creatinine

    Time frame: 12 weeks

    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.

  2. Cystatin C

    Time frame: 12 weeks

    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.

  3. Extended Glasgow Outcome Scale

    Time frame: 12 months

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

  4. Interhemispheric coherence

    Time frame: 12 months

    Quantitatie electroencephalography (EEG) measure that assess the degree of synchronization between electrical signals recorded from corresponding Right and Left brain regions. It ranges 0-1 with 1 reflecting perfect synchronization (or maximum functional connectivity).

  5. Cerebral blood flow velocity

    Time frame: 12 months

    Speed of blood flow through major intracranial arteries (middle cerebral artery in the current study), measured noninvasively using Doppler ultrasound. Typical mean middle cerebral artery velocity is 30-80 cm/s in healthy adults.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Creatine Supplementation in Pediatric Brain Injury: Brain Outcomes Optimization Through Supplementation Therapy

Acronym: BOOST

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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