Effect of Creatine on Serum and Urine Creatinine (ECSUC)
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creatine Monohydrate
Creatine Ethyl Ester
Sponsored by
About this trial
This is an interventional basic science trial for Acute Kidney Injury focused on measuring Creatine, Creatinine, Serum Creatinine, Urine Creatinine, Creatine Monohydrate, Creatine Ethyl Ester, Acute Kidney Injury, Renal, Kidney
Eligibility 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
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Creatine Monohydrate
Creatine Ethyl Ester
Arm Description
Each of the 25 subjects took Creatine Monohydrate.
Each of the 25 subjects took Creatine Ethyl Ester.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01367717
First Posted
June 6, 2011
Last Updated
September 14, 2012
Sponsor
Beth Israel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01367717
Brief Title
Effect of Creatine on Serum and Urine Creatinine
Acronym
ECSUC
Official Title
Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beth Israel Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Creatine, Creatinine, Serum Creatinine, Urine Creatinine, Creatine Monohydrate, Creatine Ethyl Ester, Acute Kidney Injury, Renal, Kidney
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Creatine Monohydrate
Arm Type
Active Comparator
Arm Description
Each of the 25 subjects took Creatine Monohydrate.
Arm Title
Creatine Ethyl Ester
Arm Type
Active Comparator
Arm Description
Each of the 25 subjects took Creatine Ethyl Ester.
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine Monohydrate
Other Intervention Name(s)
GNC Pro Performance Fruit Punch Creatine Monohydrate, Tang brand Orange Drink, manufactured by Kraft Foods
Intervention Description
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
Intervention Name(s)
Creatine Ethyl Ester
Other Intervention Name(s)
CE2 Rapid Absorption Ester Creatine: Platinum, Tang brand Orange Drink, manufactured by Kraft Foods
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum Creatinine
Description
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.
Time Frame
24 Hours
Title
Urine Creatinine
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristopher K Hunt, M.D.
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J Hoffman, M.D.
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
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Effect of Creatine on Serum and Urine Creatinine
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