UnknownPhase 3

The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis

160 participantsStarted 2022-11

Plain-language summary

This study aims to measure the effectiveness of vitamins C and E on relieving RLS symptoms in end stage renal disease patients on HD

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Arthritis
. Deep venous thrombosis
. Varicose veins or venous insufficiency
. Habitual foot tapping
. Anticonvulsants, e.g., new use of anticonvulsant drugs within6 months of screening. A stable regimen of anticonvulsants was allowed.
. Antipsychotics (haloperidol or phenothiazine derivatives)
. Antidepressants (selective serotonin reuptake inhibitors or tricyclic antidepressants)
. Antimanic (lithium)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria

Timeframe: in screening

Stop Bang

Timeframe: in screening

Hemoglobin

Timeframe: in screening

Changes in The International Restless Leg Syndrome Study Group (IRLSSG) rating scale for restless legs syndrome

Timeframe: base line then once weekly for 12 weeks

Epworth sleepiness scale (ESS)

Timeframe: base line then once every 4 weeks for 12 weeks

Medical Outcomes Study Sleep Scale (MOS)

Timeframe: base line then once every 4 weeks for 12 weeks

Suggested Immobilization Test (SIT)

Timeframe: base line then once every 4 weeks for 12 weeks

Trial details

NCT IDNCT05350124

SponsorKing Abdulaziz University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Siraj Wali

0966505606100 sowali@kau.edu.sa

View on ClinicalTrials.gov More Restless Legs Syndrome trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Arthritis
. Deep venous thrombosis
. Varicose veins or venous insufficiency
. Habitual foot tapping
. Anticonvulsants, e.g., new use of anticonvulsant drugs within6 months of screening. A stable regimen of anticonvulsants was allowed.
. Antipsychotics (haloperidol or phenothiazine derivatives)
. Antidepressants (selective serotonin reuptake inhibitors or tricyclic antidepressants)
. Antimanic (lithium)

What they're measuring

International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria

Timeframe: in screening

Stop Bang

Timeframe: in screening

Hemoglobin

Timeframe: in screening

Changes in The International Restless Leg Syndrome Study Group (IRLSSG) rating scale for restless legs syndrome

Timeframe: base line then once weekly for 12 weeks

Epworth sleepiness scale (ESS)

Timeframe: base line then once every 4 weeks for 12 weeks

Medical Outcomes Study Sleep Scale (MOS)

Timeframe: base line then once every 4 weeks for 12 weeks

Suggested Immobilization Test (SIT)

Timeframe: base line then once every 4 weeks for 12 weeks