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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Satellite Healthcare.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597025
First Posted: January 17, 2008
Last Update Posted: January 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Satellite Healthcare
January 8, 2008
January 17, 2008
January 17, 2008
December 2007
December 2009   (Final data collection date for primary outcome measure)
  • 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. ]
  • 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 ]
Same as current
No Changes Posted
  • Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period [ Time Frame: Month 3 ]
  • 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 ]
  • Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored [ Time Frame: Each month for 3 months ]
Same as current
Not Provided
Not Provided
 
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Hypoalbuminemia
  • Malnutrition
  • 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
  • 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
  • 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.
  • Active Comparator: Group A
    Center Hemodialysis patients
    Intervention: Dietary Supplement: Protein Food Bar Intelligent Indulgence
  • Active Comparator: Group B
    Center hemodialysis patients
    Intervention: Dietary Supplement: Protein Food Bar Intelligent Indulgence
  • No Intervention: Group C
    Center Hemodialysis Patients
  • Active Comparator: Group D
    Peritoneal dialysis patients
    Intervention: Dietary Supplement: Protein Food Bar Intelligent Indulgence
  • No Intervention: Group E
    Peritoneal dialysis patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
375
December 2009
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00597025
SR017PB
No
Not Provided
Not Provided
Brigitte Schiller-Moran, Satellite Healthcare, Inc.
Satellite Healthcare
Not Provided
Principal Investigator: Brigitte Schiller-Moran, MD Satellite Healthcare, Inc.
Satellite Healthcare
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP