Metabolic effects of two low protein diets in chronic kidney disease stage four to five: a randomised controlled trial
| ISRCTN | ISRCTN58881100 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58881100 |
| Secondary identifying numbers | 00138 |
- Submission date
- 26/02/2007
- Registration date
- 14/06/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Bruno Cianciaruso
Scientific
Scientific
University Federico II of Naples
Division of Nephrology
Building N°5
Via S. Pansini N°5
Naples
80131
Italy
| cianciar@unina.it |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Metabolic effects of two low protein diets in chronic kidney disease stage four to five: a randomised controlled trial |
| Study objectives | To test the best metabolic control of renal failure with a low protein diet. |
| Ethics approval(s) | Approval received from the ethics board of the University of Naples on the 15th April 1998 (ref: 29/98). |
| Health condition(s) or problem(s) studied | Nephrology; chronic kidney disease, renal failure, uraemia |
| Intervention | Two diets with different protein content: 0.55 g/kg/day versus 0.80 g/kg/day. |
| Intervention type | Other |
| Primary outcome measure | Blood levels of urea |
| Secondary outcome measures | 1. Plasma/serum levels of phosphate 2. Parathyroid hormone 3. Bicarbonate levels |
| Overall study start date | 01/01/1999 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 420 |
| Total final enrolment | 423 |
| Key inclusion criteria | 1. Age of 18 years 2. A basal value of estimated Glomerular Filtration Rate (eGFR) equal or less than 30 ml/min/1.73 m^2 3. After a three months baseline period the patients with stable renal function were deemed eligible for study |
| Key exclusion criteria | 1. Unstable renal function 2. Malignant disease, if treated with immunosuppressant drugs, or urinary protein excretion exceeding 5 g/24 hours 3. Pregnancy |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- Italy
Study participating centre
University Federico II of Naples
Naples
80131
Italy
80131
Italy
Sponsor information
University Federico II of Naples (Italy)
University/education
University/education
School of Medicine
Via s. Pansini N°5
Naples
80131
Italy
| cianciar@unina.it | |
| Website | http://www.unina.it/ |
"ROR" |
https://ror.org/05290cv24 |
Funders
Funder type
Government
Partially funded in an unrestricted manner by the Plans of Important National Interest (Progetti di Rilevante Interesse Nazionale) (PRIN) - 2001(ref: 061427) of the Italian Ministry of Universities (Italy)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | 09/05/2019 | Yes | No |
| Results article | results | 01/12/2009 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication references and total final enrolment added.
