Effect of Creatine on Serum and Urine Creatinine
Completed · Not applicable
Conditions studied: Acute Kidney Injury
In brief
Background: Creatinine (Crn) concentration is used to assess renal function via calculation of GFR (Glomerular Filtration Rate). By RIFLE (Risk, Injury, Failure, Loss, End Stage Kidney Disease) criteria, acute kidney injury (AKI) and acute renal failure (ARF) are defined by a two-fold and three-fold increase in serum Crn, respectively. Crn is a breakdown product of proteins and circulating creatine, and it is generally a benign product present in serum. Creatine is a nutritional supplement that has been available since 1993, and it is widely used among athletes today. Methods: In an IRB approved, blinded crossover trial, 25 human volunteers ingested 2 creatine supplements to determine any associated statistically significant increase in serum Crn and clinically significant increase in serum Crn to a degree associated with AKI or ARF. Urine samples were also collected to examine excretion patterns after an ingested sample. Participants ingested 10 gm of creatine ethyl ester (CEE) or creatine monohydrate (CrM) and had serum Crn assayed at 0, 1, 2, 3, 4, 5 and 24 hours. Urinary Crn levels were assayed at 0, 1.5, 3, 5 and 24 hours. Exclusion factors were any history of renal disease or use of creatine within the last month. Statistical analysis was performed by Wilcoxon Matched-Pair Signed Ranks Test and descriptive summary statistics were performed.
Key facts
- Study ID
- NCT01367717
- Run by
- Beth Israel Medical Center
- People needed
- 25
- Starts
- 2009-05-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2012-09-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age over 18
- Human
You may not qualify if…
- Use of any form of creatine within 4 weeks prior to participation in study.
- Pregnancy
- History of elevated creatinine or renal insufficiency
- History of PKU
Where it is running
- Beth Israel Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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