Restless Legs Syndrome in Hemodialysis Patients

NCT03337529 | Completed

• 1 other identifier: 10082017
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Leg Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of RLS

  8 weeks

• Risk factors

  8 weeks

Study Arms (2)

Vitamin C

EXPERIMENTAL

RLS positive patients will be assessed for the severity. They will be given 200 mg Vitamin C for 8 weeks duration. Patients will be re-assessed for the severity of restless leg syndrome.

Other: Vitamin C

Placebo

PLACEBO COMPARATOR

RLS positive patients will be assessed for the severity. They will be given 200 mg placebo for 8 weeks duration. Patients will be re-assessed for the severity of restless leg syndrome.

Other: Placebo

Interventions

Vitamin C OTHER

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

Vitamin C

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Hania Jarkas, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurologist

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: September 15, 2017
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

LE (1)