Restless Leg SyndromeNCT03337529
Restless Legs Syndrome in Hemodialysis Patients
A study testing Vitamin C in people with Restless Leg Syndrome, run by Makassed General Hospital at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Leg Syndrome
- What is being tested?
- Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Sep 2017to 15 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients under regular hemodialysis
- with no acute illness
- not hospitalized
Who cannot join
- Patients receiving:
- tricyclic antidepressants,
- selective serotonin reuptake inhibitors,
- dopamine antagonists,
- dopamine blocking,
- antiemetics,
Show all 9Show fewer
- lithium,
- sedative antihistamines,
- Patients with a history of renal stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restless Legs Syndrome in Hemodialysis Patients: Prevalence, Associated Risk Factors and Efficacy of Vitamin C as a Treatment
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.
Read the detailed 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.
- Conditions
- Restless Leg Syndrome
- Being tested
- Vitamin C, Placebo
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin COther
200 mg Vitamin C will be given on daily basis for 8 weeks
PlaceboOther
200 mg placebo will be given on daily basis for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
incidence of RLS
identify the incidence of restless legs syndrome in end stage renal disease (ESRD) patients on dialysis in Lebanon
Measured: 8 weeks
Risk factors
identify risk factors associated with RLS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start15 Sep 2017
- Primary completion15 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hania Jarkas, Makassed General Hospital
- Investigators
- Hania Jarkas, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337529
- Sponsor's protocol ID
- 10082017
- Status last verified
- May 2018
- First submitted
- 6 Nov 2017
- Last updated
- 17 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restless Legs Syndrome in Hemodialysis Patients: Prevalence, Associated Risk Factors and Efficacy of Vitamin C as a Treatment
- ClinicalTrials.gov ID
- NCT03337529
- Acronym / sponsor ID
- 10082017
- Conditions
- Restless Leg Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Other: Vitamin CRLS 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. |
| Placebo | Placebo comparator | Other: PlaceboRLS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients under regular hemodialysis
- with no acute illness
- not hospitalized
Key exclusion criteria (9 listed)
- Patients receiving:
- tricyclic antidepressants,
- selective serotonin reuptake inhibitors,
- dopamine antagonists,
- dopamine blocking,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C200 mg Vitamin C will be given on daily basis for 8 weeks | Other | Vitamin C |
| Placebo200 mg placebo will be given on daily basis for 8 weeks | Other | Placebo |
Primary outcome
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.
2 secondary outcomes
incidence of RLS
Time frame: 8 weeks
Risk factors
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hania Jarkas, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Restless Leg Syndrome, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the international restless legs syndrome (IRLS) rating scale score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.