No registrations found.
ID
Source
Brief title
Health condition
End stage renal disease patients on hemodialysis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nutritional status as assessed by nPCR, serum albumin, serum pre-albumin, serum creatinine, and dry body weight.
Secondary outcome
Phosphate binder use, Quality of Life, dietary intake and blood parameters. Nutritional status as assessed by SGA.
Background summary
Renilon 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.
Study objective
The 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.
Study design
N/A
Intervention
Duration 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.
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
PO Box 7005
Jane McKenzie
Wageningen 6700 CA
The Netherlands
+31 (0)317 467800
Jane.McKenzie@Numico-Research.nl
Inclusion criteria
End-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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL638 |
| NTR-old | NTR698 |
| Other | : Protocol Number 100059 |
| ISRCTN | ISRCTN56882109 |