Health TrialsbyHealthPanel

Creatine Supplementation in Pediatric Brain Injury

ConditionsBrain InjuryTraumatic Brain InjuryStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-25
SponsorSpaulding Rehabilitation Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Creatine monohydrate

    Dietary supplement

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

  • Microcrystalline Cellulose

    Other intervention

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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: CreatineExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

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

Time frame
12 weeks
2

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
3

Retention

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

Time frame
12 weeks
4

Dosing adherence

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

Time frame
12 weeks

Secondary outcomes

1

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
2

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
3

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
4

Interhemispheric coherence

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).

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: