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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease; Hypoalbuminemia; Malnutrition	Dietary Supplement: Protein Food Bar Intelligent Indulgence	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	375 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Study Start Date :	December 2007
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Group A; 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
Active Comparator: Group B; 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
No Intervention: Group C; Center Hemodialysis Patients
Active Comparator: Group D; 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.
No Intervention: Group E; Peritoneal dialysis patients

Outcome Measures

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Primary Outcome Measures :

1. 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. ]
2. 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 ]

Secondary Outcome Measures :

1. Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period [ Time Frame: Month 3 ]
2. 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 ]
3. Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored [ Time Frame: Each month for 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

United States, California
Satellite Healthcare, Inc.	Recruiting
Mountain View, California, United States, 94041
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Contact: Sheila Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com
Principal Investigator: Brigitte Schiller-Moran, MD
WellBound, Inc.	Recruiting
Mountain View, California, United States, 94041
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Contact: Sheila Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com
Principal Investigator: Brigitte Schiller-Moran, MD

Sponsors and Collaborators

Satellite Healthcare

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Brigitte Schiller-Moran, Satellite Healthcare, Inc.
ClinicalTrials.gov Identifier:	NCT00597025 History of Changes
Other Study ID Numbers:	SR017PB
First Posted:	January 17, 2008
Last Update Posted:	January 17, 2008
Last Verified:	December 2007

Keywords provided by Satellite Healthcare:

Malnutrition; Hypoalbuminemia; Dietary Supplements; Hemodialysis; Peritoneal Dialysis

Additional relevant MeSH terms:

Kidney Failure, Chronic; Malnutrition; Hypoalbuminemia; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases	Urologic Diseases; Nutrition Disorders; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases