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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01125033
First received: May 14, 2010
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Restless Legs Syndrome
Kidney Failure, Chronic
Drug: Vitamin C & Vitamin E
Drug: Vitamin C
Drug: Vitamin E
Drug: Vitamin C Placebo & Vitamin E Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Absolute Change in IRLS Sum Score [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events throughout the treatment phase of the study would be assessed.


Enrollment: 60
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125033

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Vice Chancellor for Research At Shiraz University of Medical Sciences, Shiraz Nephro-Urology Research Center
ClinicalTrials.gov Identifier: NCT01125033     History of Changes
Other Study ID Numbers: 86-3893
Study First Received: May 14, 2010
Last Updated: June 16, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E

Additional relevant MeSH terms:
Syndrome
Renal Insufficiency
Psychomotor Agitation
Restless Legs Syndrome
Kidney Failure, Chronic
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Renal Insufficiency, Chronic
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014