Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

Status: Recruiting
Study State Date: December 2007
Primary Completion Date: Anticipated December 2009
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: N/A

Sponsor(s):
Satellite Healthcare
 
Information By: Satellite Healthcare
Trial Identifier: NCT00597025
Official Title: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

Description:  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.

Accepts Healthy Volunteers?: No
Enrollment: 375 Anticipated
Minimum Age: 18 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  Inclusion Criteria: - Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days. - 18 years of age or older. - Must have a reasonable expectation of remaining on treatment for at least 3 months. - Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study. - Must be able to understand and sign the informed consent. - Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods. Exclusion Criteria: - Allergy to protein, milk, nuts or wheat. - Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry. - Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L. - Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease. - Hospitalization for an infectious condition within 4 weeks prior to study entry. - Planned surgery within the three month study period including planned kidney transplantation.

Conditions:
Malnutrition
Kidney Diseases
End Stage Renal Disease
Kidney Failure, Chronic
Hypoalbuminemia
Interventions:
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Dietary Supplement: Protein Food Bar Intelligent Indulgence
 
Primary Outcome Measures:
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.
Safety Issue: No

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
Safety Issue: Yes

 
Secondary Outcome Measures:
Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period
Time Frame: Month 3
Safety Issue: No

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
Safety Issue: No

Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored
Time Frame: Each month for 3 months
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Group A: Active Comparator
Center Hemodialysis patients
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients will be given one protein bar at each dialysis treatment, 3 times per week for 3 months

 
Group B: Active Comparator
Center hemodialysis patients
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients will be given 7 bars per week. In addition to the the three bars given on Hemodialysis each week, the patients will be given on the first treatment of the week four protein bars to be eaten on non-dialysis days

 
Group C: No Intervention
Center Hemodialysis Patients
 
Group D: Active Comparator
Peritoneal dialysis patients
Dietary Supplement: Protein Food Bar Intelligent Indulgence
Patients will be given a monthly supply of protein bars to provide for daily intake of one protein bar.

 
Group E: No Intervention
Peritoneal dialysis patients
 

Contacts:
Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Sheila Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com

Investigators:
Principal Investigator: Brigitte Schiller-Moran, MD, Satellite Healthcare, Inc.

Responsible Party:
Satellite Healthcare, Inc. (Brigitte Schiller-Moran)

Study Locations:
+ Show All 2 Study Locations


United States, California
Satellite Healthcare, Inc. (Recruiting)
Mountain View, California, United States
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com

WellBound, Inc. (Recruiting)
Mountain View, California, United States
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com

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