Beth Israel Medical Center
New York, 10003, United States
NCT Number: NCT01367717
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
New York, 10003, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each subject ingested 10 grams of commercially available creatine monohydrate orally. This was equivalent to two teaspoons according to the manufacturer's recommendations. The creatine was then solubilized in 8 oz. of water and 2 tablespoons of Tang brand orange flavored drink mix.
Other names: GNC Pro Performance Fruit Punch Creatine Monohydrate, Tang brand Orange Drink, manufactured by Kraft Foods
Each subject ingested 10 grams of creatine ethyl ester orally. This was equivalent to 14.25 pills according to the manufacturer's ingredient description. The pill capsules were ground into a powder, which was added to 8 oz of water along with 2 tablespoons of Tang brand orange drink.
Other names: CE2 Rapid Absorption Ester Creatine: Platinum, Tang brand Orange Drink, manufactured by Kraft Foods
Time frame: 24 Hours
Participants ingested 10 grams of creatine monohydrate or creatine ester and had serum creatinine measured at 0, 1, 2, 3, 4, 5, and 24 hours.
Time frame: 24 hours
Participants ingested 10 grams of creatine monohydrate or creatine ethyl ester and had urinary creatinine levels measured at 0, 1.5, 3, 5, and 24 hours.
Beth Israel Medical Center
Other
Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine
Acronym: ECSUC
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.
Published trials that share one or more normalized conditions with this study.
NCT06483139
Acute Kidney Injury, Blood Protein Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT07688733
Acute Kidney Injury, Blood Protein Disorders
Monterrey, Nuevo León, Mexico
View Trial DetailsNCT07654010
Acute Kidney Injury, Female Urogenital Diseases
Malatya, Osmaniye, Turkey (Türkiye)
View Trial DetailsNCT05033652
Acute Kidney Injury, Chronic Disease
Alès, France
View Trial Details