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临床试验/NCT01367717
NCT01367717已完成不适用

Effect of Creatine Monohydrate and Creatine Ethyl Ester on Serum and Urinary Creatinine

Beth Israel Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Serum Creatinine

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18

排除标准

  • 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

结局指标

主要结局

Serum Creatinine

时间窗: 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.

Urine Creatinine

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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