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 |
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.
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
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