Effect of Creatine on Serum and Urine Creatinine (ECSUC)
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|ClinicalTrials.gov Identifier: NCT01367717|
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : September 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Dietary Supplement: Creatine Monohydrate Dietary Supplement: Creatine Ethyl Ester||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Active Comparator: Creatine Monohydrate
Each of the 25 subjects took Creatine Monohydrate.
Dietary Supplement: Creatine Monohydrate
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.
Active Comparator: Creatine Ethyl Ester
Each of the 25 subjects took Creatine Ethyl Ester.
Dietary Supplement: Creatine Ethyl Ester
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.
- Serum Creatinine [ 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.
- Urine Creatinine [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367717
|United States, New York|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Kristopher K Hunt, M.D.||Beth Israel Medical Center|
|Study Director:||Robert J Hoffman, M.D.||Beth Israel Medical Center|