Condition category
Not Applicable
Date applied
19/10/2006
Date assigned
27/10/2006
Last edited
29/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Graham

ORCID ID

Contact details

1 Lantwit Road
Treforrest
Cardiff
CF37 1DL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

280361999

Study information

Scientific title

Short term recombinant human Growth Hormone administration increases strength and power, but does it improve sporting performance in anabolic-androgenic steroid users?

Acronym

rhGH on performance

Study hypothesis

Short-term recombinant human Growth Hormone (rhGH) administration increases strength, power and endurance performance in healthy, abstinent Anabolic-Androgenic Steroid (AAS) using weight lifters.

Ethics approval

University of Glamorgan ethics committee. Originally approved on the 22nd January 2002 (ref: SEC3), amended and final approval was granted on the 20th November 2002 (ref: SEC7).

Study design

Double blind experimental trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Anabolic-Androgenic Steroid (AAS) users

Intervention

All physiological tests were performed in the same order for both the experimental group and the controls. Subjects were familiarised with testing procedures. Subjects were examined daily over a period of six weeks between the hours of 09:00 and 11:00 and were anonymous to each other.

Subjects were administered rhGH, under supervision, by subcutaneous abdominal injection, in a controlled hygienic environment, for six consecutive days in a dosage of 0.058 International Units (IU)/kg/day (0.019 mg/kg/day). Subjects were examined prior to the commencement of rhGH administration (day one), one day after six days administration (day seven), and eight days after cessation (day 14). Dietary intake was strictly monitored, using a fourteen day dietary recall.

The control group were an exercise control group and did not take an active substance.

Intervention type

Drug

Phase

Not Specified

Drug names

Recombinant human Growth Hormone

Primary outcome measures

Increased strength, power and endurance performance indices.

Secondary outcome measures

1. Reduced body fat
2. Increased fat free mass
3. Increased heart rate

Overall trial start date

01/08/2004

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy individual weight lifters, who were previous experienced users of AAS, in a 12 week abstinent phase

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

48

Participant exclusion criteria

Positive urinalysis for ergogenic aids

Recruitment start date

01/08/2004

Recruitment end date

01/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glamorgan
1 Lantwit Road Treforrest
Cardiff
CF37 1DL
United Kingdom

Sponsor information

Organisation

University of Glamorgan

Sponsor details

1 Lantwit Road
Treforrest
Cardiff
CF37 1DL
United Kingdom

Sponsor type

University/education

Website

http://www.glam.ac.uk/

Funders

Funder type

University/education

Funder name

University of Glamorgan (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17324600

Publication citations

Additional files

Editorial Notes

29/06/2016: Publication reference added