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



Status:Completed
Conditions:Food Studies, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology, Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:December 2007
End Date:December 2009
Contact:Brigitte Schiller-Moran, MD
Email:schillerb@satellitehealth.com
Phone:650-404-3640

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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.


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.
We found this trial at
2
sites
Mountain View, California 94041
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Mountain View, California 64041
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