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

Phase 2

Completed

• Conditions: Restless Legs Syndrome; Kidney Failure, Chronic
• Interventions: Drug: Vitamin C & Vitamin E; Drug: Vitamin C Placebo & Vitamin E Placebo; Drug: Vitamin C; Drug: Vitamin E

• Registration Number: NCT01125033
• Lead Sponsor: Shiraz University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	8 Weeks	Number of participants with adverse events throughout the treatment phase of the study would be assessed.

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of