Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites

Sponsor
Loughborough University (Other)
Overall Status
Completed
CT.gov ID
NCT00682123
Collaborator
UK Sport, 40 Bernard Street, London, WC1N 1ST (Other)
20
1
6
3.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: 19-norandrostendione
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Supplement Contamination: Detection of Nandrolone Metabolites in Urine After Administration of Small Doses of a Nandrolone Precursor
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations [All urine passed for 24h following supplement ingestion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy male and female volunteers aged between 18 - 35 years of age
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loughborough University, School of Sport and Exercise Sciences Loughborough Leicestershire United Kingdom LE11 3TU

Sponsors and Collaborators

  • Loughborough University
  • UK Sport, 40 Bernard Street, London, WC1N 1ST

Investigators

  • Principal Investigator: Ronald Maughan, PhD, Loughborough University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00682123
Other Study ID Numbers:
  • R05-P39
First Posted:
May 22, 2008
Last Update Posted:
May 22, 2008
Last Verified:
May 1, 2008

Study Results

No Results Posted as of May 22, 2008