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Sponsored by: |
Satellite Healthcare |
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Information provided by: | Satellite Healthcare |
ClinicalTrials.gov Identifier: | NCT00597025 |
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 | Intervention |
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End Stage Renal Disease Hypoalbuminemia Malnutrition |
Dietary Supplement: Protein Food Bar Intelligent Indulgence |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin |
Estimated Enrollment: | 375 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Active Comparator
Center Hemodialysis patients
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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
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Group B: Active Comparator
Center hemodialysis patients
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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
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Group C: No Intervention
Center Hemodialysis Patients
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Group D: Active Comparator
Peritoneal dialysis patients
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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.
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Group E: No Intervention
Peritoneal dialysis patients
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brigitte Schiller-Moran, MD | 650-404-3640 | schillerb@satellitehealth.com |
Contact: Sheila Doss, RN, CCRA | 650-404-3621 | dosss@satellitehealth.com |
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 |
Principal Investigator: | Brigitte Schiller-Moran, MD | Satellite Healthcare, Inc. |
Responsible Party: | Satellite Healthcare, Inc. ( Brigitte Schiller-Moran ) |
Study ID Numbers: | SR017PB |
Study First Received: | January 8, 2008 |
Last Updated: | January 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00597025 |
Health Authority: | United States: Institutional Review Board |
Malnutrition Hypoalbuminemia Dietary Supplements Hemodialysis Peritoneal Dialysis |
Renal Insufficiency Malnutrition Urologic Diseases Hematologic Diseases Blood Protein Disorders Renal Insufficiency, Chronic |
Hypoalbuminemia Kidney Failure, Chronic Nutrition Disorders Kidney Diseases Kidney Failure |
Hypoproteinemia |