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Trial record 3 of 19 for:    Satellite Healthcare

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

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ClinicalTrials.gov Identifier: NCT00597025
Recruitment Status : Unknown
Verified December 2007 by Satellite Healthcare.
Recruitment status was:  Recruiting
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:
Satellite Healthcare

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 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

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



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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597025


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.

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    Key Record Dates
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