Dietary Protein Requirements in Hemodialysis Patients

End-Stage Renal Disease Clinical Trial

Official title:

Dietary Protein Intake and Its Effect on Nitrogen Balance in Maintenance Hemodialysis (MHD) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194114
• Other study ID #: 10602
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 16, 2014
• Start date: January 2004
• Est. completion date: January 2008

Study information

• Verified date: July 2014
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 to PEM, low dietary protein intake (DPI) is often a contributing factor. The usual DPI of MHD patients in about 1.0 g protein/kg/day, whereas expert groups recommend = 1.20 g protein/kg/day. However, these recommendations are based upon few studies, often of insufficient duration, that were usually carried out with obsolete types of dialysis therapy.

We will examine the response to different levels of dietary protein intake (0.6-1.3 g protein/kg/day) under classical balance techniques with carefully controlled dietary intakes, living, conditions, and collection of nitrogen outputs and carefully measured nitrogen intakes and outputs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Renal Failure
• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Other:
• Protein Diet
Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.

Locations

Country	Name	City	State
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitrogen Balance		One year	No