The nutritional, cardiovascular and immunological effect of daily subcutaneous ghrelin in dialysis patients with evidence of malnutrition
| ISRCTN | ISRCTN43319045 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43319045 |
| Protocol serial number | N/A |
| Sponsor | Hammersmith Hospitals NHS Trust (UK) |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- Submission date
- 06/03/2006
- Registration date
- 22/06/2006
- Last edited
- 20/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Choi
Scientific
Scientific
West London Renal and Transplant Centre
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Ghrelin treatment has beneficial effects on the disordered nutritional, cardiovascular and immunological physiology of dialysis patients. |
| Ethics approval(s) | Approved by the Riverside Research Ethics Committee on 01/02/2006, reference number: 05/Q0401/132 |
| Health condition(s) or problem(s) studied | Malnutrition or renal failure |
| Intervention | Subcutaneous ghrelin versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ghrelin |
| Primary outcome measure(s) |
1. Blood pressure |
| Key secondary outcome measure(s) |
1. Food intake |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | Dialysis patients at West London Renal and Transplant Centre, Hammersmith Hospital with evidence of malnutrition |
| Key exclusion criteria | 1. Anaemia 2. Over 75 years of age 3. Recent illness |
| Date of first enrolment | 13/03/2006 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
West London Renal and Transplant Centre
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2009 | Yes | No |
