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Effect of Creatine on Serum and Urine Creatinine

NCT ID: NCT01367717

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Acute Kidney Injury

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Creatine Monohydrate

Each of the 25 subjects took Creatine Monohydrate.

Group Type ACTIVE_COMPARATOR

Creatine Monohydrate

Intervention Type 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.

Creatine Ethyl Ester

Each of the 25 subjects took Creatine Ethyl Ester.

Group Type ACTIVE_COMPARATOR

Creatine Ethyl Ester

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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GNC Pro Performance Fruit Punch Creatine Monohydrate Tang brand Orange Drink, manufactured by Kraft Foods CE2 Rapid Absorption Ester Creatine: Platinum Tang brand Orange Drink, manufactured by Kraft Foods

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beth Israel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristopher K Hunt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Robert J Hoffman, M.D.

Role: STUDY_DIRECTOR

Beth Israel Medical Center

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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034-09

Identifier Type: -

Identifier Source: org_study_id