Dietary Protein Requirements in Hemodialysis Patients (NCT02194114) | Clinical Trial Compass
CompletedNot Applicable
Dietary Protein Requirements in Hemodialysis Patients
United States13 participantsStarted 2004-01
Plain-language 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 (DPI) that will maintain nitrogen balance is 1.00 g protein/kg/day, but that a safe intake that maintains balance in almost all MHD patients is about 1.25g protein/kg/day.
Who can participate
Age range25 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Nitrogen Balance
Timeframe: One year
Trial details
NCT IDNCT02194114
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center