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Completed

NCT Number: NCT01367717

Effect of Creatine on Serum and Urine Creatinine

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Medical Center

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GNC Pro Performance Fruit Punch Creatine Monohydrate, Tang brand Orange Drink, manufactured by Kraft Foods

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.

Other names: CE2 Rapid Absorption Ester Creatine: Platinum, Tang brand Orange Drink, manufactured by Kraft Foods

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Registry information

Official study title

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

Acronym: ECSUC

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 7, 2011
Registry last updated
Sep 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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