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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29108

Enrollment

Registered

2006-06-06

Start date

2003-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage renal disease patients on hemodialysis.

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Inadequate dialysis (Kt/V 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 outcomes

Primary

Measure	Time frame
Nutritional status as assessed by nPCR, serum albumin, serum pre-albumin, serum creatinine, and dry body weight.	—

Secondary

Measure	Time frame
Phosphate binder use, Quality of Life, dietary intake and blood parameters. Nutritional status as assessed by SGA.	—

Contacts

Public ContactJane McKenzie

Numico Research B.V., PO Box 7005

Jane.McKenzie@Numico-Research.nl+31 (0)317 467800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)