Effect of Creatine on Serum and Urine Creatinine (ECSUC)

Beth Israel Lahey Health

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Dietary Supplement: Creatine Monohydrate; Dietary Supplement: Creatine Ethyl Ester

Study type: Interventional

Funder types: Other

Identifiers

NCT01367717

034-09

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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25 participants in 2 patient groups

Creatine Monohydrate

Active Comparator group

Description:

Each of the 25 subjects took Creatine Monohydrate.

Treatment:

Dietary Supplement: Creatine Monohydrate

Creatine Ethyl Ester

Active Comparator group

Description:

Each of the 25 subjects took Creatine Ethyl Ester.

Treatment:

Dietary Supplement: Creatine Ethyl Ester