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临床试验/NCT00682123
NCT00682123已完成1 期

Supplement Contamination: Detection of Nandrolone Metabolites in Urine After Administration of Small Doses of a Nandrolone Precursor

Loughborough University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年3月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations

研究概览

简要总结

There is compelling evidence that some dietary supplements consumed by the general population are manufactured and stored under conditions that lead to contamination of the end product with small amounts of extraneous materials. In most cases, this is harmless, but for athletes liable to drug testing as a consequence of their participation in sport, the potential consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality control procedures for pharmaceutical products normally specify the absence of contaminants at a level of more than 0.1%, ie 1mg/g. However, in the case of an anabolic steroid such as nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg (Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d), such as for example creatine, this means that a contamination level of something closer to 0.00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as 10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive doping test in all volunteers testing. This is one thousand times less that the purity level specified for pharmaceutical agents and at this level, these contaminants are without any pharmacological action.

Proposals are under development to regulate the sale of dietary supplements for use by athletes to avoid accidental doping positives as a result of ingestion of contaminated supplements. This requires a knowledge of the amounts of contaminant that is likely to cause problems. The aim of the present study was to examine the urinary excretion pattern of nandrolone metabolites following 1µg, 2.5µg and 5µg doses of 19-norandrostendione in both male and female subjects. The quantity of 19-norandrostenedione administered in this study is representative of the amount previously reported as an undeclared contaminant in some dietary supplements. Given the speculation surrounding positive doping cases being attributed to ingestion of sports supplements contaminated with pro-hormones, this presents an important consideration for both athletes and doping agencies, as well as supplement manufacturers.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female volunteers aged between 18 - 35 years of age

排除标准

  • Any potential participant competing in sport at a level where there is even a remote possibility of being called for a drugs test was excluded

结局指标

主要结局

Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations

时间窗: All urine passed for 24h following supplement ingestion

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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