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

Primary Purpose

Restless Legs Syndrome, Kidney Failure, Chronic

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin C & Vitamin E
Vitamin C
Vitamin E
Vitamin C Placebo & Vitamin E Placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Vitamin C & Vitamin E.

Vitamin C & Placebo

Vitamin E & Placebo

Double Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with adverse events
Number of participants with adverse events throughout the treatment phase of the study would be assessed.

Full Information

First Posted
May 14, 2010
Last Updated
June 16, 2011
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01125033
Brief Title
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
Acronym
ShirazUMS
Official Title
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
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Legs Syndrome, Kidney Failure, Chronic
Keywords
Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C & Vitamin E.
Arm Type
Experimental
Arm Description
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
Arm Title
Vitamin C & Placebo
Arm Type
Experimental
Arm Description
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
Arm Title
Vitamin E & Placebo
Arm Type
Experimental
Arm Description
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
Arm Title
Double Placebo
Arm Type
Placebo Comparator
Arm Description
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin C & Vitamin E
Intervention Description
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
Intervention Name(s)
Vitamin C
Intervention Description
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Description
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin C Placebo & Vitamin E Placebo
Intervention Description
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Primary Outcome Measure Information:
Title
Absolute Change in IRLS Sum Score
Description
Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Number of participants with adverse events throughout the treatment phase of the study would be assessed.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamideh Akbari, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Mahdi Sagheb, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sahar Sohrabi Nazari, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Kazem Fallahzadeh, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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

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