Kidney Failure, Chronic, Restless Legs Syndrome
Conditions
Keywords
Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
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.
Interventions
DRUGVitamin 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
DRUGVitamin C
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
DRUGVitamin E
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
DRUGVitamin C Placebo & Vitamin E Placebo
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in IRLS Sum Score | 8 Weeks | Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 8 Weeks | Number of participants with adverse events throughout the treatment phase of the study would be assessed. |
Countries
Iran
Outcome results
None listed