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

Kidney Failure, Chronic Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125033
• Other study ID #: 86-3893
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 14, 2010
• Last updated: June 16, 2011
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2011
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Psychomotor Agitation
• Renal Insufficiency
• Restless Legs Syndrome
• Syndrome

Intervention

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
• Vitamin C
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
• Vitamin E
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
• Vitamin C Placebo & Vitamin E Placebo
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with adverse events	Number of participants with adverse events throughout the treatment phase of the study would be assessed.	8 Weeks