Restless Legs SyndromePhase 3NCT05350124
The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis
A Phase 3 study testing Ascorbic acid and Tocopherol in people with Restless Legs Syndrome and End Stage Renal Disease, run by King Abdulaziz University.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Restless Legs Syndrome, End Stage Renal Disease
- What is being tested?
- Ascorbic acid and Tocopherol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2023
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.
Who cannot join
- Secondary causes of RLS Medications (list included in section C below) iron deficiency or peripheral neuropathy
- Presence of RLS-mimicking disorders:
- Arthritis
- Deep venous thrombosis
- Varicose veins or venous insufficiency
- Habitual foot tapping
Show all 31Show fewer
- Patients receiving medications that could trigger RLS:
- 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)
- Patients on medications or with conditions that may interfere with vitamin C \& E absorption:
- Celiac disease
- Crohn's disease
- Chronic pancreatitis
- Cystic fibrosis
- Weight-reduction drugs
- Chemotherapy and radiotherapy
- Patients with contraindications for vitamin C \& E supplements:
- Blood disorders, e.g., thalassemia, G6PD, sickle cell disease and hemochromatosis
- Other conditions like diabetic patients, oxalate nephropathy, nephrolithiasis and vitamin E or C allergy
- Unstable vital signs
- Retinal eye disease
- Cancers
- Liver disease
- Vitamin K deficiency
- For women only:
- Pregnancy (positive pregnancy test at screening)
- Currently breastfeeding
- Use of oral contraceptives or start of menopausal hormone therapy within 3 months of baseline
- History of vitamin E or C intolerance
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to measure the effectiveness of vitamins C and E on relieving RLS symptoms in end stage renal disease patients on HD
Read the detailed description
double-blind placebo-controlled trial of 12 weeks duration on end stage renal disease (ESRD) patients on HD with RLS.
All ESRD patients on HD will be screened clinically for RLS using the five diagnostic criteria of IRLSSG by trained physicians. then the Quastioniare will be filled and inclusion and exclusion criteria be checked sleep study must be done.
Each patient will then undergo a full sleep study using level 2 polysomnography at home. Periodic leg movements with sleep (PLMs) index and leg movements index (LM) before sleep onset will be recorded as well as other variables
Then Subjects will then be randomly assigned by blocked randomization into four groups, each group will include 40 patients. A. Group 1: Will receive vitamin C (200 mg) tablet and vitamin E (a-tocopherol) (400 mg) capsule every day for 12 weeks. B. Group 2: Will receive vitamin E (400 mg) capsule and placebo every day for 12 weeks.
- Group 3: Will receive vitamin C (200 mg) tablet and placebo every day for 12 weeks. D. Group 4: Will receive two placebo every day for 12 weeks. Of note, the personal responsible for randomization will not be involved in the trial.
- Conditions
- Restless Legs Syndrome, End Stage Renal Disease
- Being tested
- Ascorbic acid, Tocopherol, Placebo capsule
- Medical subject headings
- Restless Legs Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called Vitamin C
vitamin C (200 mg) capsule
TocopherolDrug
Also called Vitamin E
vitamin E (400 IU) capsule
Placebo capsuleDrug
Also called Inactive substance
Placebo one pill only
Placebo capsuleDrug
Also called Inactive substance
Placebo two pills only
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Vitamin C (200 mg) capsule, and vitamin E (400 IU) capsule every day for 12 weeks. Receives: Drug: Ascorbic acid; Drug: Tocopherol |
| Group 2 | Experimental | Vitamin C (200 mg) capsule, and placebo every day for 12 weeks. Receives: Drug: Ascorbic acid; Drug: Placebo capsule |
| Group 3 | Experimental | Vitamin E (400 IU) capsule, and placebo every day for 12 weeks. Receives: Drug: Tocopherol; Drug: Placebo capsule |
| Group 4 | Experimental | Placebo capsule (2 pills) every day for 12 weeks. Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria
The IRLSSG is a validated and reliable questionnaire. Well-trained physicians will aid patients in completing this questionnaire and perform clinical examination. It consists of five yes/no questions, subjects will be considered to have RLS if their answers are yes to all five questions
Measured: in screening
Stop Bang
The STOP-Bang questionnaire includes the four questions used in the STOP questionnaire plus four additional demographic queries, for a total of eight dichotomous (yes/no) questions related to the clinical features of sleep apnea (snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference and male gender). For each question, answering "yes" scores 1, a "no" response scores 0, and the total score ranges from 0 to 8.
Low Risk: Yes to 0 - 2 questions
Intermediate Risk: Yes to 3 - 4 questions
High Risk: Yes to 5 - 8 questions
or Yes to 2 or more of 4 STOP questions + male gender
or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2
or Yes to 2 or more of 4 STOP questions + neck circumference 16 inches / 40cm
Measured: in screening
Hemoglobin
Participants with normal levels between 12 - 15 g/dl Participants with levels below 12 or above 15 will be considered abnormal
Measured: in screening
Changes in The International Restless Leg Syndrome Study Group (IRLSSG) rating scale for restless legs syndrome
That consists of 10 questions scored from 0-4 with a total score ranging from 0-40 in which RLS severity is directly proportional to the total score. Meaning the higher the score, the worse and severe the symptoms.
Measured: base line then once weekly for 12 weeks
Epworth sleepiness scale (ESS)
It is a self-administered questionnaire that measures the severity of excessive daytime sleepiness (EDS) containing 8 questions, each question is given a score from 0 to 3 with a total score of 0-24. A score above 10 is considered abnormal i.e. in keeping with EDS
Measured: base line then once every 4 weeks for 12 weeks
Medical Outcomes Study Sleep Scale (MOS)
A 12-item scale that investigates six factors including; sleep initiation, respiratory problems, maintenance, perceived adequacy and somnolence. With higher score indicating higher sleep disturbance.
Measured: base line then once every 4 weeks for 12 weeks
Suggested Immobilization Test (SIT)
prior to the sleep recording. at 45-degree angle with their legs outstretched. avoid moving voluntarily for the entire duration of the test. Surface EMG from the left and right anterior tibialis muscles is used to quantify leg movements. The latter are scored according to the criteria (movements lasting between 0.5 and 10 seconds, separated by intervals of 4 to 90 seconds and arising in series of at least 4 consecutive movements). The SIT periodic leg movements index represents the number of periodic leg movements per hour of immobility. Patients report severity of leg discomfort on a visual analogue scale (VAS) ranging from 0 (no discomfort) to 100 (extreme discomfort) every 10 minutes during the SIT. The mean leg discomfort score is assessed using the average of the 7 values, as well as the discomfort severity at the end of the test (time 60 minutes), the maximum leg discomfort during the test, and the variation between the lowest and the highest values recorded during the test
Measured: base line then once every 4 weeks for 12 weeks
Restless Leg Syndrome (RLS) Symptoms Diary
The (RLS) Symptom Diary is a convenient tool to record information on your daily (RLS) symptoms, their duration, sleep patterns and possible triggers such as nicotine, alcohol or caffeine. to identify what influences, triggers or worsen the (RLS) symptoms
Measured: base line then daily for the last 2 weeks
Polysomnography
Polysomnography (SOMNO Medics Plus; SOMNOmedics, Randersacker, Germany) consists of continuous recordings from surface leads for electroencephalography (EEG), electrooculography, electromyography (submental and bilateral anterior tibialis muscles), electrocardiography, nasal pressure, nasal and oral airflow (thermocouple), chest and abdominal impedance belts for respiratory muscle efforts, pulse oximetry for oxygen saturation and pulse rate, a tracheal microphone for snoring, and body position sensors for sleep position. PSG records are scored manually according to the American Academy of Sleep Medicine (AASM) 2020 scoring
Measured: base line then once every 4 weeks for 12 weeks
Hemoglobin A1C
Participants will be considered normal if the level is within 4.2 - 6.3 % Participants with a level higher than 6.3% will be considered abnormal
Measured: In screening
Vitamin D
Participants will be considered normal if the level is within 75 - 250 nmol/L Participants will be considered abnormal if the level is less than 75 or higher than 250 nmol/L
Measured: In screening
Serum Iron
Participants will be considered normal if the level is within 6 - 26 umol/L
Measured: In screening
Total Iron Binding Capacity
Participants will be considered normal if the level is within 25 - 92 umol/L
Measured: In screening
Ferritin
Participants will be considered normal if the level is within 13-150 ng/ml
Measured: In screening
Magnesium
Participants will be considered normal if the level is within 1.7 - 2.2 mg/dL
Measured: In screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study startNov 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization into four groups, each group will include 40 patients. A. Group 1: Will receive vitamin C (200 mg) tablet and vitamin E (a-tocopherol) (400 mg) capsule every day for 12 weeks. B. Group 2: Will receive vitamin E (400 mg) capsule and placebo every day for 12 weeks. C. Group 3: Will receive vitamin C (200 mg) tablet and placebo every day for 12 weeks. D. Group 4: Will receive two placebo every day for 12 weeks. Of note, the personal responsible for randomization will not be involved in the trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siraj Omar Wali, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350124
- Sponsor's protocol ID
- VIT.C&E RLS on HM
- Status last verified
- Aug 2022
- First submitted
- 17 Mar 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis
- ClinicalTrials.gov ID
- NCT05350124
- Acronym / sponsor ID
- VIT.C&E RLS on HM
- Conditions
- Restless Legs Syndrome, End Stage Renal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Apr 2022 (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.
This study aims to measure the effectiveness of vitamins C and E on relieving RLS symptoms in end stage renal disease patients on HD
Detailed description
double-blind placebo-controlled trial of 12 weeks duration on end stage renal disease (ESRD) patients on HD with RLS.
All ESRD patients on HD will be screened clinically for RLS using the five diagnostic criteria of IRLSSG by trained physicians. then the Quastioniare will be filled and inclusion and exclusion criteria be checked sleep study must be done.
Each patient will then undergo a full sleep study using level 2 polysomnography at home. Periodic leg movements with sleep (PLMs) index and leg movements index (LM) before sleep onset will be recorded as well as other variables
Then Subjects will then be randomly assigned by blocked randomization into four groups, each group will include 40 patients. A. Group 1: Will receive vitamin C (200 mg) tablet and vitamin E (a-tocopherol) (400 mg) capsule every day for 12 weeks. B. Group 2: Will receive vitamin E (400 mg) capsule and placebo every day for 12 weeks.
- Group 3: Will receive vitamin C (200 mg) tablet and placebo every day for 12 weeks. D. Group 4: Will receive two placebo every day for 12 weeks. Of note, the personal responsible for randomization will not be involved in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- randomization into four groups, each group will include 40 patients. A. Group 1: Will receive vitamin C (200 mg) tablet and vitamin E (a-tocopherol) (400 mg) capsule every day for 12 weeks. B. Group 2: Will receive vitamin E (400 mg) capsule and placebo every day for 12 weeks. C. Group 3: Will receive vitamin C (200 mg) tablet and placebo every day for 12 weeks. D. Group 4: Will receive two placebo every day for 12 weeks. Of note, the personal responsible for randomization will not be involved in the trial.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Ascorbic acid, Drug: TocopherolVitamin C (200 mg) capsule, and vitamin E (400 IU) capsule every day for 12 weeks. |
| Group 2 | Experimental | Drug: Ascorbic acid, Drug: Placebo capsuleVitamin C (200 mg) capsule, and placebo every day for 12 weeks. |
| Group 3 | Experimental | Drug: Tocopherol, Drug: Placebo capsuleVitamin E (400 IU) capsule, and placebo every day for 12 weeks. |
| Group 4 | Experimental | Drug: Placebo capsulePlacebo capsule (2 pills) every day for 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.
Key exclusion criteria (31 listed)
- Secondary causes of RLS Medications (list included in section C below) iron deficiency or peripheral neuropathy
- Arthritis
- Deep venous thrombosis
- Varicose veins or venous insufficiency
- Habitual foot tapping
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 |
|---|---|---|
| Ascorbic acidAlso: Vitamin Cvitamin C (200 mg) capsule | Drug | Group 1, Group 2 |
| TocopherolAlso: Vitamin Evitamin E (400 IU) capsule | Drug | Group 1, Group 3 |
| Placebo capsuleAlso: Inactive substancePlacebo one pill only | Drug | Group 2, Group 3 |
| Placebo capsuleAlso: Inactive substancePlacebo two pills only | Drug | Group 4 |
Primary outcome
International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria
Time frame: in screening
The IRLSSG is a validated and reliable questionnaire. Well-trained physicians will aid patients in completing this questionnaire and perform clinical examination. It consists of five yes/no questions, subjects will be considered to have RLS if their answers are yes to all five questions
Stop Bang
Time frame: in screening
The STOP-Bang questionnaire includes the four questions used in the STOP questionnaire plus four additional demographic queries, for a total of eight dichotomous (yes/no) questions related to the clinical features of sleep apnea (snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference and male gender). For each question, answering "yes" scores 1, a "no" response scores 0, and the total score ranges from 0 to 8. Low Risk: Yes to 0 - 2 questions Intermediate Risk: Yes to 3 - 4 questions High Risk: Yes to 5 - 8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference 16 inches / 40cm
Hemoglobin
Time frame: in screening
Participants with normal levels between 12 - 15 g/dl Participants with levels below 12 or above 15 will be considered abnormal
Changes in The International Restless Leg Syndrome Study Group (IRLSSG) rating scale for restless legs syndrome
Time frame: base line then once weekly for 12 weeks
That consists of 10 questions scored from 0-4 with a total score ranging from 0-40 in which RLS severity is directly proportional to the total score. Meaning the higher the score, the worse and severe the symptoms.
Epworth sleepiness scale (ESS)
Time frame: base line then once every 4 weeks for 12 weeks
It is a self-administered questionnaire that measures the severity of excessive daytime sleepiness (EDS) containing 8 questions, each question is given a score from 0 to 3 with a total score of 0-24. A score above 10 is considered abnormal i.e. in keeping with EDS
Medical Outcomes Study Sleep Scale (MOS)
Time frame: base line then once every 4 weeks for 12 weeks
A 12-item scale that investigates six factors including; sleep initiation, respiratory problems, maintenance, perceived adequacy and somnolence. With higher score indicating higher sleep disturbance.
Suggested Immobilization Test (SIT)
Time frame: base line then once every 4 weeks for 12 weeks
prior to the sleep recording. at 45-degree angle with their legs outstretched. avoid moving voluntarily for the entire duration of the test. Surface EMG from the left and right anterior tibialis muscles is used to quantify leg movements. The latter are scored according to the criteria (movements lasting between 0.5 and 10 seconds, separated by intervals of 4 to 90 seconds and arising in series of at least 4 consecutive movements). The SIT periodic leg movements index represents the number of periodic leg movements per hour of immobility. Patients report severity of leg discomfort on a visual analogue scale (VAS) ranging from 0 (no discomfort) to 100 (extreme discomfort) every 10 minutes during the SIT. The mean leg discomfort score is assessed using the average of the 7 values, as well as the discomfort severity at the end of the test (time 60 minutes), the maximum leg discomfort during the test, and the variation between the lowest and the highest values recorded during the test
Restless Leg Syndrome (RLS) Symptoms Diary
Time frame: base line then daily for the last 2 weeks
The (RLS) Symptom Diary is a convenient tool to record information on your daily (RLS) symptoms, their duration, sleep patterns and possible triggers such as nicotine, alcohol or caffeine. to identify what influences, triggers or worsen the (RLS) symptoms
Polysomnography
Time frame: base line then once every 4 weeks for 12 weeks
Polysomnography (SOMNO Medics Plus; SOMNOmedics, Randersacker, Germany) consists of continuous recordings from surface leads for electroencephalography (EEG), electrooculography, electromyography (submental and bilateral anterior tibialis muscles), electrocardiography, nasal pressure, nasal and oral airflow (thermocouple), chest and abdominal impedance belts for respiratory muscle efforts, pulse oximetry for oxygen saturation and pulse rate, a tracheal microphone for snoring, and body position sensors for sleep position. PSG records are scored manually according to the American Academy of Sleep Medicine (AASM) 2020 scoring
Hemoglobin A1C
Time frame: In screening
Participants will be considered normal if the level is within 4.2 - 6.3 % Participants with a level higher than 6.3% will be considered abnormal
Vitamin D
Time frame: In screening
Participants will be considered normal if the level is within 75 - 250 nmol/L Participants will be considered abnormal if the level is less than 75 or higher than 250 nmol/L
Serum Iron
Time frame: In screening
Participants will be considered normal if the level is within 6 - 26 umol/L
Total Iron Binding Capacity
Time frame: In screening
Participants will be considered normal if the level is within 25 - 92 umol/L
Ferritin
Time frame: In screening
Participants will be considered normal if the level is within 13-150 ng/ml
Magnesium
Time frame: In screening
Participants will be considered normal if the level is within 1.7 - 2.2 mg/dL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ascorbic acid and Tocopherol in people with Restless Legs Syndrome and End Stage Renal Disease, run by King Abdulaziz University.
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 1 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siraj Wali (0966505606100, sowali@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria (time frame: in screening). The study lists 15 primary outcomes in all. 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 24 Aug 2022.