Positive Doping Tests in SportsPhase 1/2NCT00682123
Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites
A Phase 1/2 study testing 19-norandrostendione in people with Positive Doping Tests in Sports, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Positive Doping Tests in Sports
- What is being tested?
- 19-norandrostendione
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Sep 2006
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged between 18 - 35 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University, School of Sport and Exercise Sciences
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: Supplement Contamination: Detection of Nandrolone Metabolites in Urine After Administration of Small Doses of a Nandrolone Precursor
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.
- Conditions
- Positive Doping Tests in Sports
- Being tested
- 19-norandrostendione
- Keywords
- 19-norandrostenedione, steroids, drugs in sport, World Anti-Doping Agency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19-norandrostendioneDietary supplement
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations
Measured: All urine passed for 24h following supplement ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startMar 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Positive Doping Tests in SportsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- UK Sport, 40 Bernard Street, London, WC1N 1ST
- Investigators
- Ronald Maughan, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682123
- Sponsor's protocol ID
- R05-P39
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 22 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Geyer H, Parr MK, Mareck U, Reinhart U, Schrader Y, Schanzer W. Analysis of non-hormonal nutritional supplements for anabolic-androgenic steroids - results of an international study. Int J Sports Med. 2004 Feb;25(2):124-9. doi: 10.1055/s-2004-819955.
PubMed 14986195Maughan RJ. Contamination of dietary supplements and positive drug tests in sport. J Sports Sci. 2005 Sep;23(9):883-9. doi: 10.1080/02640410400023258.
PubMed 16195040Judkins C, Watson P, Russell C. A crossover study of 19-nor-androstenedione contamination in sports supplements: preliminary findings. Proceedings of the 5th International congress on Medical Polymers. Cologne, Germany 2006.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplement Contamination: Detection of Nandrolone Metabolites in Urine After Administration of Small Doses of a Nandrolone Precursor
- ClinicalTrials.gov ID
- NCT00682123
- Acronym / sponsor ID
- R05-P39
- Conditions
- Positive Doping Tests in Sports
- Keywords
- 19-norandrostenedione, steroids, drugs in sport, World Anti-Doping Agency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- UK Sport, 40 Bernard Street, London, WC1N 1ST
- Study start
- Mar 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 22 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and female volunteers aged between 18 - 35 years of age
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 19-norandrostendioneVolunteers 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. | Dietary supplement | – |
Primary outcome
Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations
Time frame: All urine passed for 24h following supplement ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
- Background: PubMed 14986195Geyer H, Parr MK, Mareck U, Reinhart U, Schrader Y, Schanzer W. Analysis of non-hormonal nutritional supplements for anabolic-androgenic steroids - results of an international study. Int J Sports Med. 2004 Feb;25(2):124-9. doi: 10.1055/s-2004-819955.
- Background: PubMed 16195040Maughan RJ. Contamination of dietary supplements and positive drug tests in sport. J Sports Sci. 2005 Sep;23(9):883-9. doi: 10.1080/02640410400023258.
- BackgroundJudkins C, Watson P, Russell C. A crossover study of 19-nor-androstenedione contamination in sports supplements: preliminary findings. Proceedings of the 5th International congress on Medical Polymers. Cologne, Germany 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Maughan, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 19-norandrostendione in people with Positive Doping Tests in Sports, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary 19-norandrosterone (19-NA) and 19-noretiocholanolone (19-NE) concentrations (time frame: All urine passed for 24h following supplement ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00682123, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2008.