Status:
COMPLETED
Protein Supplementation in Dialysis Patients
Lead Sponsor:
University of Utah
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Poor nutritional status as evidenced by low body mass index, low muscle mass or low serum albumin is a strong predictor of morbidity and mortality in dialysis patients. Hypercatabolism induced by infl...
Detailed Description
Design: Open labeled trial. Recruitment and Randomization: Men and women aged 18 or older receiving care at the University of Utah dialysis centers. Study procedures: Men and women on hemodialysis f...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects (men and women) on hemodialysis for at least 3 months
- Inflammation (high sensitivity CRP \> 3 mg/dL)
- Body Mass Index \< 23 kg/m2; or low muscle mass as evidenced by serum creatinine \< 8 mg/dL in the presence of anuria (urine output \< 200 ml/d) and adequate dialysis (Urea Reduction Ratio \> 65%).
- Exclusion criteria
- Pregnant subjects
- Subjects who are prisoners
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01855295
Start Date
November 1 2009
End Date
August 1 2012
Last Update
August 11 2016
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