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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03337529
Other study ID # 10082017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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