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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Restless Legs Syndrome; Kidney Failure, Chronic

Treatments: Drug: Vitamin C Placebo & Vitamin E Placebo; Drug: Vitamin C & Vitamin E; Drug: Vitamin E; Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01125033

86-3893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Vitamin C & Vitamin E.

Experimental group

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

Treatment:

Drug: Vitamin C & Vitamin E

Vitamin C & Placebo

Experimental group

Description:

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

Treatment:

Drug: Vitamin C

Vitamin E & Placebo

Experimental group

Description:

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

Treatment:

Drug: Vitamin E

Double Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin C Placebo & Vitamin E Placebo