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Protein Supplementation in Dialysis Patients

NCT01855295 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-08-11

No results posted yet for this study

Summary

Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum albumin is a strong predictor of morbidity and mortality in dialysis patients. Hypercatabolism induced by inflammation is widely considered the cause of uremic malnutrition even though there is no clear evidence that hemodialysis patients with elevated C-reactive protein (CRP) levels are at greater risk of losing weight or muscle mass. Conversely, there is little data on whether dialysis patients with malnutrition and elevated C-reactive protein levels would gain muscle mass with protein supplementation.

The hypothesis is that protein supplementation during dialysis will improve muscle mass, functional status and quality of life in inflamed malnourished hemodialysis patients. Therefore, the objectives of the current proposal are to examine in malnourished (body mass index \< 23 kg/m2 or serum creatinine \< 8 mg/dL) hemodialysis patients with inflammation (high sensitivity CRP \> 3 mg/dL), the effects of protein supplementation on

1. Muscle mass as determined by creatinine kinetics
2. Functional status as assessed by 6 min walk
3. Quality of life as assessed by Short Form -12 survey

Conditions

Interventions

DIETARY_SUPPLEMENT

Protein Supplement

During the treatment phase, study subjects are advised to increase protein intake to 1.2 g/kg/day for 12 weeks. In addition to any protein supplementation the participant is on, supervised supplementation on each dialysis session is provided. Each participant receives 45 grams of liquid protein supplement (Provide Sugar Free produced by Provide Nutrition LC) at each dialysis treatment for additional 12 weeks for total study duration of 24 weeks.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2012-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855295 on ClinicalTrials.gov