Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Hemodialysis Clinical Trial

— NAC  

Official title:

Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440869
• Other study ID #: R21-DK077350 (completed)
• Secondary ID: DK-077350-01
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2007
• Last updated: March 2, 2010
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dialysis
• End-Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• N-acetylcysteine
600 mg po bid
• placebo
bid oral dosing

Locations

Country	Name	City	State
United States	San Francisco VA Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in quadriceps muscle endurance during intermittent submaximal contractions		6 days	No
Primary	change in exercise-induced markers of oxidative stress		8 days	No