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

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

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome; Kidney Failure, Chronic
• Intervention / Treatment: Drug: Vitamin C & Vitamin E; Drug: Vitamin C; Drug: Vitamin E; Drug: Vitamin C Placebo & Vitamin E Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of
      • Shiraz University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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.	Drug: Vitamin C; 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.	Drug: Vitamin E; 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.	Drug: Vitamin C Placebo & Vitamin E Placebo; The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Investigators: Principal Investigator: Hamideh Akbari, MD, Shiraz University of Medical Sciences; Study Chair: Mohammad Mahdi Sagheb, MD, Shiraz University of Medical Sciences; Principal Investigator: Sahar Sohrabi Nazari, MD, Shiraz University of Medical Sciences; Principal Investigator: Mohammad Kazem Fallahzadeh, MD, Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): January 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (ESTIMATE): May 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Renal Insufficiency, Chronic; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Kidney Failure, Chronic; Renal Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin E; Tocopherols; alpha-Tocopherol; Vitamins; Tocotrienols; Ascorbic Acid
• Other Study ID Numbers: 86-3893