Status:
COMPLETED
Dietary Protein Requirements in Hemodialysis Patients
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Chronic Renal Failure
End-Stage Renal Disease
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The primary purpose of this study is to assess dietary protein requirements in clinically stable maintenance hemodialysis (MHD) patients. It is hypothesized that the average dietary protein intake (DP...
Detailed Description
A high proportion of maintenance hemodialysis (MHD) patients have protein-energy malnutrition (PEM) which is a powerful predictor of high morbidity and mortality. Although inflammation may contribute ...
Eligibility Criteria
Inclusion
- Ages from 30 years through 65 years
- Both men and women and all ethnic and racial groups
- Treatment with MHD for 6 months or greater
- Hemoglobin of at least 11 g/dL
- Neurological examination indicating no severe neuropathy
- A negative test for peripheral arterial occlusive disease
Exclusion
- Obesity: body weight greater than \>115% of standard
- History of active cancer other than basal cell carcinoma
- Symptomatic severe ischemic heart disease, uncontrolled serious dysrhythmias, uncontrolled congestive heart failure, poorly controlled hypertension, severe musculoskeletal disease, arthritis or amputations of the lower extremities
- Insulin dependent or insulin independent diabetes mellitus
- Severe lung or liver disease, uncontrolled asthma, active vasculitis. Severe chronic infection or any other acute or chronic inflammatory or catabolic illnesses
- Psychosis, inability to give informed consent, evidence that patient will not comply with study protocol
- Alcohol or other recreational drug abuse
- Patients who received L-carnitine or anabolic hormones within the previous 6 months
- Pregnancy
- Patients who are physically and/or psychologically incapable of undergoing the protocol
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02194114
Start Date
January 1 2004
End Date
January 1 2008
Last Update
July 18 2014
Active Locations (1)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509