Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis (NAC)
Primary Purpose
End-Stage Renal Disease, Dialysis, Hemodialysis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring N-acetylcysteine, oxidative stress, muscle fatigue, end-stage renal disease, hemodialysis
Eligibility Criteria
Inclusion Criteria:
- age greater than 18 years
- undergoing hemodialysis for 3 months or more or healthy control without kidney disease
Exclusion Criteria:
- inability to give informed consent
- diagnosis of diabetes mellitus
- musculoskeletal contraindication to exercise
- infection requiring intravenous antibiotics within 2 months
- hospitalization within 2 months
- ingestion of antioxidant supplements within one month
- requirement for systemic anticoagulation
- estimated GFR <60 ml/min/1.73 m2 for healthy controls
Sites / Locations
- San Francisco VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N-acetylcysteine
placebo
Arm Description
Active
placebo
Outcomes
Primary Outcome Measures
change in quadriceps muscle endurance during intermittent submaximal contractions
change in exercise-induced markers of oxidative stress
Secondary Outcome Measures
Full Information
NCT ID
NCT00440869
First Posted
February 26, 2007
Last Updated
March 2, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00440869
Brief Title
Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis
Acronym
NAC
Official Title
Effects of N-acetylcysteine on Muscle Fatigue in ESRD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.
Detailed Description
Muscle dysfunction is a major problem for patients with end-stage renal disease (ESRD). Specifically, these patients experience approximately three-fold greater muscle fatigue of the lower extremities during intermittent submaximal contractions than healthy control subjects. Thus, a treatment that could ameliorate muscle fatigue in this population has the potential to increase endurance during activities of daily living and improve quality of life. Dialysis patients have been shown to have high levels of various markers of oxidative stress, and oxidative stress has been associated with excessive muscle fatigue in other patient populations, but this link has not been established in the ESRD population.
Comparisons: The amount of muscle fatigue during intermittent submaximal quadriceps exercise between dialysis patients and controls will be compared. In addition, the degree of exercise-induced increase in markers of oxidative stress in muscle and in plasma will be compared between dialysis patients and controls and between dialysis patients who have received N-acetylcysteine for 6 days and those who have received placebo capsules.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Dialysis, Hemodialysis
Keywords
N-acetylcysteine, oxidative stress, muscle fatigue, end-stage renal disease, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
Active
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
N-acetylcysteine
Intervention Description
600 mg po bid
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
bid oral dosing
Primary Outcome Measure Information:
Title
change in quadriceps muscle endurance during intermittent submaximal contractions
Time Frame
6 days
Title
change in exercise-induced markers of oxidative stress
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age greater than 18 years
undergoing hemodialysis for 3 months or more or healthy control without kidney disease
Exclusion Criteria:
inability to give informed consent
diagnosis of diabetes mellitus
musculoskeletal contraindication to exercise
infection requiring intravenous antibiotics within 2 months
hospitalization within 2 months
ingestion of antioxidant supplements within one month
requirement for systemic anticoagulation
estimated GFR <60 ml/min/1.73 m2 for healthy controls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten L Johansen, MD
Organizational Affiliation
University of California, San Francisco, San Francisco VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis
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