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Effects of N-acetylcysteine on Muscle Fatigue in Hemodialysis

Effects of N-acetylcysteine on Muscle Fatigue in ESRD

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440869
Acronym
NAC
Enrollment
30
Registered
2007-02-27
Start date
2007-03-31
Completion date
2009-12-31
Last updated
2010-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis, End-Stage Renal Disease, Hemodialysis

Keywords

N-acetylcysteine, oxidative stress, muscle fatigue, end-stage renal disease, hemodialysis

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.

Interventions

DIETARY_SUPPLEMENTN-acetylcysteine

600 mg po bid

DIETARY_SUPPLEMENTplacebo

bid oral dosing

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
change in quadriceps muscle endurance during intermittent submaximal contractions6 days
change in exercise-induced markers of oxidative stress8 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026