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Effect of Creatine on Serum and Urine Creatinine (ECSUC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01367717
First received: June 6, 2011
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention
Acute Kidney Injury
 Dietary Supplement: Creatine Monohydrate
Dietary Supplement: Creatine Ethyl Ester

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Serum Creatinine [ Time Frame: 24 Hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • GNC Pro Performance Fruit Punch Creatine Monohydrate
  • Tang brand Orange Drink, manufactured by Kraft Foods
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.
Other Names:
  • CE2 Rapid Absorption Ester Creatine: Platinum
  • Tang brand Orange Drink, manufactured by Kraft Foods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367717

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
Principal Investigator: Kristopher K Hunt, M.D. Beth Israel Medical Center
Study Director: Robert J Hoffman, M.D. Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01367717     History of Changes
Other Study ID Numbers: 034-09
Study First Received: June 6, 2011
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Creatine
Creatinine
Serum Creatinine
Urine Creatinine
Creatine Monohydrate
 Creatine Ethyl Ester
Acute Kidney Injury
Renal
Kidney

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013