Effect of Creatine on Serum and Urine Creatinine

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Creatine Ethyl Ester

• Registration Number: NCT01367717
• Lead Sponsor: Beth Israel Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2011-06-06
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Creatine Monohydrate	Creatine Monohydrate	Each of the 25 subjects took Creatine Monohydrate.
Creatine Ethyl Ester	Creatine Ethyl Ester	Each of the 25 subjects took Creatine Ethyl Ester.

Primary Outcome Measures

Name	Time	Method
Serum Creatinine	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	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.

Trial Locations

Locations (1)

Beth Israel Medical Center; 🇺🇸 New York, New York, United States