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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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
  • Experimental: Vitamin C & Placebo
    • The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
  • Experimental: Vitamin E & Placebo
    • The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
  • Placebo Comparator: Double Placebo
    • The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Absolute Change in IRLS Sum Score
    • Time Frame: 8 Weeks
    • Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population

Secondary Measures

  • Number of participants with adverse events
    • Time Frame: 8 Weeks
    • Number of participants with adverse events throughout the treatment phase of the study would be assessed.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
  • Patients who are stable on HD without any internment illness or admission

Exclusion Criteria

  • Patients who have renal stone
  • Patients who receive medications with RLS aggravating or alleviating properties

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Vice Chancellor for Research At Shiraz University of Medical Sciences, Shiraz Nephro-Urology Research Center
  • Overall Official(s)
    • Hamideh Akbari, MD, Principal Investigator, Shiraz University of Medical Sciences
    • Mohammad Mahdi Sagheb, MD, Study Chair, Shiraz University of Medical Sciences
    • Sahar Sohrabi Nazari, MD, Principal Investigator, Shiraz University of Medical Sciences
    • Mohammad Kazem Fallahzadeh, MD, Principal Investigator, Shiraz University of Medical Sciences

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