Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites
Condition: Positive Doping Tests in Sports
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    


Intervention name(s): 19-norandrostendione
Intervention type(s): Dietary Supplement
Intervention description(s): Volunteers recieved 500mL of water containing 5g of creatine monohydrate and either 1.0μg, 2.5μg or 5.0μg of 19-norandrostendione in a single-blind crossover manner.
The amount of 19-norandrostendione administered was trivial, and far less than the amounts shown to be present in many popular dietary supplements. The recommended dosage according to the distributors is 100 mg 2-3 times daily, so the administered daily dose was not more than 0.05% of the recommended dose. This dose has no measurable physiological or pharmacological effects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: 19-norandrostenedione; steroids; drugs in sport; World Anti-Doping Agency