Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
Completed · Not applicable
Conditions studied: End Stage Renal Disease, Hypoalbuminemia, Malnutrition
In brief
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.
Key facts
- Study ID
- NCT00597025
- Run by
- Satellite Healthcare
- People needed
- 375
- Starts
- 2007-12-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2020-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Satellite Healthcare, Inc. — Mountain View, California, United States
- WellBound, Inc. — Mountain View, California, United States
Full record on ClinicalTrials.gov
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