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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Restless Legs Syndrome, Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Vitamin C & Vitamin E
* Drug: Vitamin C
* Drug: Vitamin E
* Drug: Vitamin C Placebo & Vitamin E Placebo


Participation Criteria
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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 Exclusion Criteria: Patients who have renal stone Patients who receive medications with RLS aggravating or alleviating properties

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C & Vitamin E.<br>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 & Vitamin E<br>* 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<br>|
| Experimental: Vitamin C & Placebo<br>The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks. | Drug: Vitamin C<br>* The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.<br>|
| Experimental: Vitamin E & Placebo<br>The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks. | Drug: Vitamin E<br>* The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.<br>|
| Placebo Comparator: Double Placebo<br>The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks. | Drug: Vitamin C Placebo & Vitamin E Placebo<br>* The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Number of participants with adverse events throughout the treatment phase of the study would be assessed. | 8 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E