The efficacy of disease-specific nutritional support compared with usual treatment in hemodialysis patients

Completed

• Conditions: End-stage renal disease; Urological and Genital Diseases; Renal disease

• Registration Number: ISRCTN56882109
• Lead Sponsor: umico Research B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

End-stage renal disease patients on hemodialysis treatment:
1. Requiring thrice-weekly hemodialysis for at least three 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. Body mass index (BMI) >30 kg/m^2
5. Use of any investigational drug
6. Nutritional supplementation within the last two months
7. Requiring complete enteral nutrition
8. Age <18 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
utritional status as assessed by:<br>1. nPCR<br>2. Serum albumin<br>3. Serum pre-albumin<br>4. Serum creatinine<br>5. Dry body weight.

Secondary Outcome Measures

Name	Time	Method
1. Phosphate binder use<br>2. Quality of life<br>3. Dietary intake<br>4. Blood parameters<br>5. Nutritional status as assessed by subjective global assessment (SGA)