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Completed

NCT Number: NCT01125033

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

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.

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Key information

Conditions

Restless Legs Syndrome Chronic Disease Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C & Vitamin E

Drug

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

Drug

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

Vitamin E

Drug

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

Drug

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

Primary outcomes

  1. Absolute Change in IRLS Sum Score

    Time frame: 8 Weeks

    Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: 8 Weeks

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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study 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

Acronym: ShirazUMS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 18, 2010
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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