Restless Legs Syndrome in Hemodialysis Patients

Restless Leg Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337529
• Other study ID #: 10082017
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: May 2018
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Syndrome

Intervention

Other:
• Vitamin C
200 mg Vitamin C will be given on daily basis for 8 weeks
• Placebo
200 mg placebo will be given on daily basis for 8 weeks

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the international restless legs syndrome (IRLS) rating scale score	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.	8 weeks
Secondary	incidence of RLS	identify the incidence of restless legs syndrome in end stage renal disease (ESRD) patients on dialysis in Lebanon	8 weeks
Secondary	Risk factors	identify risk factors associated with RLS	8 weeks