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The efficacy of disease specific nutritional support compared with usual treatment in hemodialysis (HD) patients.


- candidate number2116
- NTR NumberNTR698
- ISRCTNISRCTN56882109
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR6-jun-2006
- Secondary IDsProtocol Number 100059 
- Public TitleThe efficacy of disease specific nutritional support compared with usual treatment in hemodialysis (HD) patients.
- Scientific TitleThe efficacy of disease specific nutritional support compared with usual treatment in hemodialysis (HD) patients.
- ACRONYMRenilon 7.5 study.
- hypothesisThe nutritional status of patients supplemented with Renilon 7.5 for 3 months will be improved compared with patients who receive the standard treatment. Nutritional status will be assessed by a significant improvement after 3 months of treatment by the following parameters: nPCR, serum albumin, serum pre-albumin, serum creatinine or dry-body weight.
- Healt Condition(s) or Problem(s) studiedHemodialysis, Renal disease
- Inclusion criteriaEnd-stage renal disease patients on hemodialysis treatment:
1. requiring thrice weekly hemodialysis for at least 3 months;
2. stable disease (no recent hospitalizations except for minor access-related stays);
3. C-reactive protein<20 mg/L;
4. nPCR<1.0;
5. informed consent.
- Exclusion criteria1. Inadequate dialysis (Kt/V < 1.2);
2. peritoneal dialysis in the last three months;
3. serum albumin > 40 g/L;
4. BMI > 30 kg/m2;
5. use of any investigational drug;
6. nutritional supplementation within the last two months;
7. requiring complete enteral nutrition;
8. age < 18 years.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2003
- planned closingdate1-sep-2005
- Target number of participants88
- InterventionsDuration intervention: 3 Months.
Intervention group: Standard therapy and additionally daily a nutritional energy dense (2kcal/ml) supplement containing 7.5 g/100ml of demineralised whey protein and very low amounts of minerals (especially phosphate) which provides 500 kcal of energy and 18.8 gram protein. Control group: all subjects in the control group received standard therapy.
- Primary outcomeNutritional status as assessed by nPCR, serum albumin, serum pre-albumin, serum creatinine, and dry body weight.
- Secondary outcomePhosphate binder use, Quality of Life, dietary intake and blood parameters. Nutritional status as assessed by SGA.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Jane McKenzie
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. D. Fouque
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsNephrol Dial Transplant. 2008 Sep;23(9):2902-10. Epub 2008 Apr 11.
- Brief summaryRenilon 7.5 was developed to provide HD patients with adequate energy and protein with very low amounts of minerals. HD patients with a low protein intake were randomized in this controlled parallel design study to use the test product for an intervention period of 3 months. Nutritional status, phosphate binder use, Quality of Life, dietary intake and blood parameters were evaluated at regular intervals throughout the intervention period.
- Main changes (audit trail)
- RECORD6-jun-2006 - 11-sep-2008


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