Creatine Supplementation in Pediatric Brain Injury

NCT07756060 | Not Yet Recruiting

• 1 other identifier: 2026P001727
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Brain Injury; Traumatic Brain Injury; Stroke

Keywords

creatine; rehabilitation

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

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

  12 weeks

• Attrition

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

  12 weeks

• Retention

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

  12 weeks

• Dosing adherence

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

  12 weeks

Secondary Outcomes (5)

• Creatinine

  12 weeks

• Cystatin C

  12 weeks

• Extended Glasgow Outcome Scale

  12 months

• Interhemispheric coherence

  12 months

• Cerebral blood flow velocity

  12 months

Study Arms (2)

Creatine

EXPERIMENTAL

Dietary Supplement: Creatine monohydrate

Control

PLACEBO COMPARATOR

Other: Microcrystalline Cellulose

Interventions

Creatine monohydrate DIETARY_SUPPLEMENT

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

Creatine

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

Control

Eligibility Criteria

• Age: 8 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Stroke

Interventions

Creatine; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Model Details: Placebo controlled, double blind trial

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08