Effect of Creatine on Serum and Urine Creatinine

NCT01367717 | Completed DMC

• 1 other identifier: 034-09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

Creatine; Creatinine; Serum Creatinine; Urine Creatinine; Creatine Monohydrate; Creatine Ethyl Ester; Acute Kidney Injury; Renal; Kidney

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Creatine Monohydrate

ACTIVE COMPARATOR

Each of the 25 subjects took Creatine Monohydrate.

Dietary Supplement: Creatine Monohydrate

Creatine Ethyl Ester

ACTIVE COMPARATOR

Each of the 25 subjects took Creatine Ethyl Ester.

Dietary Supplement: Creatine Ethyl Ester

Interventions

Creatine Monohydrate DIETARY_SUPPLEMENT

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.

Also known as: GNC Pro Performance Fruit Punch Creatine Monohydrate, Tang brand Orange Drink, manufactured by Kraft Foods

Creatine Monohydrate

Creatine Ethyl Ester DIETARY_SUPPLEMENT

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.

Also known as: CE2 Rapid Absorption Ester Creatine: Platinum, Tang brand Orange Drink, manufactured by Kraft Foods

Creatine Ethyl Ester

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18
• Human

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Creatine; creatine ethyl ester

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kristopher K Hunt, M.D.

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

• Robert J Hoffman, M.D.

  Beth Israel Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

US (1)