NCT01125033

Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients

Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Restless Legs Syndrome
• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Vitamin C & Vitamin E	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
DRUG	Vitamin C	The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
DRUG	Vitamin E	The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
DRUG	Vitamin C Placebo & Vitamin E Placebo	The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-01-01
• Completion: 2009-02-01
• First posted: 2010-05-18
• Last updated: 2011-06-17

Locations

1 site across 1 country: Iran