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NCT01367717 · ClinicalTrials.gov registry record · NA
Effect of Creatine on Serum and Urine Creatinine
A NA study, sponsored by Beth Israel Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01367717: Completed NA study, sponsored by Beth Israel Medical Center.
NCT01367717 is a NA study that has completed, run by Beth Israel Medical Center. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367717, a NA study, has completed, sponsored by Beth Israel Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Creatine Monohydrate
- DIETARY_SUPPLEMENT Creatine Ethyl Ester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-05 |
| Est. Completion | 2009-06 |
| Phase | NA |
What the finished NCT01367717 record still lists
NCT01367717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Creatine Monohydrate is the first listed.
NCT01367717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01367717 about?
NCT01367717 is a clinical study titled "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...
What is the current status of trial NCT01367717?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2009-05. Estimated completion is 2009-06.
What interventions are being tested in trial NCT01367717?
The interventions under investigation include: Creatine Monohydrate (DIETARY_SUPPLEMENT), Creatine Ethyl Ester (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01367717?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01367717's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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