- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367717
Effect of Creatine on Serum and Urine Creatinine (ECSUC)
Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Beth Israel Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Creatine Monohydrate
Each of the 25 subjects took 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.
Other Names:
|
Active Comparator: Creatine Ethyl Ester
Each of the 25 subjects took 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 Hours
|
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.
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristopher K Hunt, M.D., Beth Israel Medical Center
- Study Director: Robert J Hoffman, M.D., Beth Israel Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 034-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on Creatine Monohydrate
-
Texas A&M UniversityNutraboltCompletedDietary Modification
-
Texas A&M UniversityNutraboltCompletedDietary Supplementation
-
Massachusetts General HospitalCompletedHuntington's Disease (HD)United States
-
Dynamical Business and Science Society - DBSS International...CES University; INDEPORTES AntioquiaCompleted
-
The Cleveland ClinicCompletedHypercholesterolemia | Weakness | Cramps | AchesUnited States
-
Perry RenshawCompletedMajor Depressive DisorderUnited States
-
University of UtahNational Cancer Institute (NCI)RecruitingFatigue | Sedentary Lifestyle | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8United States
-
Psychiatric Research Unit, Region Zealand, DenmarkUniversity of Southern DenmarkNot yet recruitingMild Traumatic Brain Injury | Concussion, Brain
-
University of UtahRecruitingMajor Depressive DisorderUnited States
-
Massachusetts General HospitalNational Institutes of Health (NIH)CompletedHuntington's DiseaseUnited States