Skip to main content
OpenTrials
Completed

NCT Number: NCT03337529

Restless Legs Syndrome in Hemodialysis Patients

Restless legs syndrome (RLS) is defined as the spontaneous movement of the limbs (mainly legs) associated with unpleasant - painful sensation which is relieved by moving the affected limb. It is a common disorder in hemodialysis patients that leads to insomnia, impaired daytime functioning and quality of life. Symptoms of RLS are estimated to affect up to 25% of patients on dialysis when the international RLS diagnostic criteria are applied. Various pharmacological and non-pharmacological interventions have been used to treat primary RLS. However, the evidence for use of these interventions in people with End stage renal disease is not well established; and some have serious side effects. Because high oxidative stress has been implicated in the pathogenesis of RLS, investigators thought of evaluating the efficacy of vitamin C in reducing the severity of RLS symptoms in hemodialysis patients in this randomized, double-blind, placebo-controlled, two arm parallel trial. To note that only two studies were done worldwide that proved the efficacy of vitamin C in those patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Restless Leg Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

The investigators are proposing to carry out a clinical trial. Around 100 stable hemodialysis adult patients at Makassed general hospital dialysis center and around 150 patients at Sahel general hospital and Zahraa hospital will be assessed according to the international RLS criteria. The data on individual, clinical and laboratory indices will be obtained from patients' recorded files and interviews. The investigators will compare the RLS group versus the non RLS group according to these factors to find the independently associated factors for RLS in dialysis patients.

Those who fulfill all four diagnostic criteria for RLS (confirmed independently by 2 neurologists) will be classified as "RLS positive" and will be asked to answer 10 questions on the international RLS study group (IRLSSG) rating scale. The IRLSSG rating scale was also used to evaluate the severity of RLS symptoms. These patients will be randomly allocated to two parallel groups to receive vitamin C (200 mg) or placebo for eight weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients under regular hemodialysis
  • with no acute illness
  • not hospitalized

Exclusion criteria

  • Patients receiving:
  • tricyclic antidepressants,
  • selective serotonin reuptake inhibitors,
  • dopamine antagonists,
  • dopamine blocking,
  • antiemetics,
  • lithium,
  • sedative antihistamines,
  • Patients with a history of renal stones

Treatment and study plan

Vitamin C

Other

200 mg Vitamin C will be given on daily basis for 8 weeks

Placebo

Other

200 mg placebo will be given on daily basis for 8 weeks

Primary outcomes

  1. change in the international restless legs syndrome (IRLS) rating scale score

    Time frame: 8 weeks

    change in the IRLS rating scale sum score from baseline to the end of treatment.The scale ranges between 0 and 40 which is the total score. A score between 31 and 40, indicates very severe RLS. A score between 21 and 30 indicates severe RLS. A score between 11 and 20 indicates moderate RLS. A score between 1 and 10 indicates mild RLS and a score of 0 means no RLS.

Secondary outcomes

  1. incidence of RLS

    Time frame: 8 weeks

    identify the incidence of restless legs syndrome in end stage renal disease (ESRD) patients on dialysis in Lebanon

  2. Risk factors

    Time frame: 8 weeks

    identify risk factors associated with RLS

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Restless Legs Syndrome in Hemodialysis Patients: Prevalence, Associated Risk Factors and Efficacy of Vitamin C as a Treatment

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 9, 2017
Registry last updated
May 17, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.