The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.
RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
Shiraz University of Medical Sciences
Shiraz, Fars, Iran
Absolute Change in IRLS Sum Score
Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population
Time frame: 8 Weeks
Number of participants with adverse events
Number of participants with adverse events throughout the treatment phase of the study would be assessed.
Time frame: 8 Weeks
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The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.