A randomised dose comparison study of recombinant human growth hormone effects on metabolism markers in children with growth hormone (GH) deficiency
| ISRCTN | ISRCTN44127724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44127724 |
| Secondary identifying numbers | N0220117222 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr NP Wright
Scientific
Scientific
Division of Child Health
Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 222 2000 |
|---|
Study information
| Study design | Randomised dose comparison study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is the response to growth hormone dose dependent and what are the best markers to evaluate the response? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Growth hormone deficiency |
| Intervention | Patients will attend a screening visit (combined with the usual visit to teach child and parent how to inject GH and familiarise them with the pen) for collection of informed consent (patients and parent/guardian). Demographic data, medical history, auxology, pubertal development and concomitant medication details will have been collected in outpatients. All these data are routinely collected as part of the normal clinical process. Randomisation to one of three dose regimes will then take place. At entry to the study biological samples will be collected - 10 to 12 ml of blood and 24 h urine collection. These will currently be an additional investigation. Further assessment of auxological data and pubertal staging will take place after 3 months. Repeat biological samples (10 to 12 ml of blood and 24 h urine collection) will be collected. Venesection routinely takes place after 3 months treatment for clinical reasons to facilitate monitoring of insulin-like growth factor (IGF-1). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Recombinant human growth hormone |
| Primary outcome measure | Measurements: Blood samples will be sent to central laboratories for analysis. Parameters to be analysed are as follows: Glucose, HbA1C, insulin, total cholesterol, triglycerides, high density lipoproteins (HDL) and low density lipoprotein (LDL) cholesterol; bone-specific isoenzymes: calcaemia, phosphoraemia, alkaline phosphatase; markers of bone formation and resorption: osteocalcin, N-telopeptide, C-telopeptide, total deoxypyridinoline and type 3 procollagen; insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 3 (IGF-BP3), ALS, IGF-BP1; dehydroepiandrosterone sulphate (DHEA-S), testosterone, antimullerian hormone (AMH) (boys only); free thyroxine (FT4), leptin; parathyroid hormone (PTH) and vitamin D (25OH-D). Evaluation of primary efficacy endpoint: This is an investigational study with a principal objective of identifying primary endpoints from a battery of biological markers for later use in a second study. Consequently this study does not have any pre-specified primary outcome measures. |
| Secondary outcome measures | Evaluation of secondary efficacy endpoints: For each of the biological markers, an appropriate parametric or non-parametric statistical analysis will be employed to investigate differences between dose groups at the 3-month assessment while adjusting for appropriate co-variates. |
| Overall study start date | 01/06/2002 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 5 |
| Key inclusion criteria | Recruitment and number of subjects: Maximum recruitment of five pre-pubertal newly diagnosed GH-deficient patients in whom a clinical decision is made that they would benefit from treatment with GH and who wish to take part in study (subject to inclusion/exclusion criteria in accordance with protocol). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Child Health
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Industry
Sheffield Childrens Hospital NHS Trust (UK)
No information available
Serono
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
