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 64041
1325
mi
from
Mountain View, CA
Click here to add this to my saved trials
Mountain View, California 94041
1324
mi
from
Mountain View, CA
Click here to add this to my saved trials