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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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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

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Restless Legs Syndrome Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Vitamin C & Vitamin E

Intervention Type DRUG

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

Vitamin C & Placebo

The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.

Vitamin E & Placebo

The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.

Group Type EXPERIMENTAL

Vitamin E

Intervention Type DRUG

The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.

Double Placebo

The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Group Type PLACEBO_COMPARATOR

Vitamin C Placebo & Vitamin E Placebo

Intervention Type DRUG

The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Interventions

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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

Intervention Type DRUG

Vitamin C

The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.

Intervention Type DRUG

Vitamin E

The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.

Intervention Type DRUG

Vitamin C Placebo & Vitamin E Placebo

The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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