Effect of Creatine on Serum and Urine Creatinine

Acute Kidney Injury Clinical Trial

— ECSUC  

Official title:

Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367717
• Other study ID #: 034-09
• Status: Completed
• Phase: N/A
• First received: June 6, 2011
• Last updated: September 14, 2012
• Start date: May 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2012
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18

• Human

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Creatinine	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.	24 Hours	Yes
Primary	Urine Creatinine	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.	24 hours	Yes