Sakellaris · The Journal of trauma 2006 · open-label randomized pilot trial · n=39

Prevention of complications related to traumatic brain injury in children and adolescents with creatine administration: an open label randomized pilot study.

Cited 114 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled trial

PubMed 16917445 · doi:10.1097/01.ta.0000230269.46108.d5 · record verified 2026-08-26

What was done

A prospective, open-label randomized pilot trial evaluated the neuroprotective effects of oral creatine in 39 children and adolescents aged 1 to 18 years with traumatic brain injury (TBI). Participants in the intervention arm received 0.4 g/kg/day of creatine in an oral suspension daily for 6 months. Categorical outcomes between cases and controls were evaluated using the chi-square test.

What was found

Creatine administration was reported to improve duration of post-traumatic amnesia, intubation duration, intensive care unit stay, disability, recovery, locomotion, and sociability, though absolute numerical values were not reported in the abstract. Statistically significant improvements were observed in cognitive function (p < 0.001), personality/behavior (p < 0.001), self-care (p = 0.029), and communication (p = 0.018). No adverse effects were observed.

Why it matters

This trial provides early preliminary evidence that post-acute creatine supplementation may enhance functional and neurobehavioral recovery after pediatric brain injury.

Limits

The study is limited by a small sample size (n = 39) and an open-label design lacking placebo control or blinding, creating high risk for observer and reporting bias. Baseline injury severity, exact group numbers, and absolute effect sizes or confidence intervals are omitted from the abstract.

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