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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00597025
First received: January 8, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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
End Stage Renal Disease
Hypoalbuminemia
Malnutrition
 Dietary Supplement: Protein Food Bar Intelligent Indulgence

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Satellite Healthcare:

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. ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Brigitte Schiller-Moran, Satellite Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00597025     History of Changes
Other Study ID Numbers: SR017PB
Study First Received: January 8, 2008
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Satellite Healthcare:
Malnutrition
Hypoalbuminemia
Dietary Supplements
Hemodialysis
Peritoneal Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Malnutrition
Hypoalbuminemia
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Nutrition Disorders
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013