Clinical Trial: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Brief Summary: This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.
Detailed Summary:
Sponsor: Satellite Healthcare
Current Primary Outcome:
- The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period. [ Time Frame: Each month for the three months. ]
- Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate. [ Time Frame: Each month for 3 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period [ Time Frame: Month 3 ]
- Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars. [ Time Frame: Each month for 3 months ]
- Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored [ Time Frame: Each month for 3 months ]
Original Secondary Outcome: Same as current
Information By: Satellite Healthcare
Dates:
Date Received: January 8, 2008
Date Started: December 2007
Date Completion: December 2009
Last Updated: January 8, 2008
Last Verified: December 2007
