Protein Supplementation in Dialysis Patients

Vanderbilt University

Status and phase: Terminated; Phase 2

Conditions: End Stage Renal Disease

Treatments: Dietary Supplement: Pro-Stat

Study type: Interventional

Funder types: Other

Identifiers

NCT00367198

060587

Details and patient eligibility

About

The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
• Adequately dialyzed (Kt/V > 1.2).
• Age 18-75

Exclusion criteria

• Pregnant women.
• Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included.
• Patients hospitalized within the last month prior to the study.
• Patients with malfunctioning arterial-venous access [recirculation and/or blood flow < 500 ml/min for an arterial-venous graft (AVG) or <400 ml/min for an arterial-venous fistula (AVF)] Patients receiving steroids and/or other immunosuppressive agents.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

6 participants in 4 patient groups

1

Active Comparator group

Description:

30 ml per serving

Treatment:

Dietary Supplement: Pro-Stat

2

Active Comparator group

Description:

60 ml per serving

Treatment:

Dietary Supplement: Pro-Stat

3

No Intervention group

Description:

chronic hemodialysis patients

4

No Intervention group

Description:

healthy subjects