End Stage Renal Disease, Restless Legs Syndrome
Conditions
Brief 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
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. 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.
Interventions
DRUGAscorbic acid
vitamin C (200 mg) capsule
DRUGTocopherol
vitamin E (400 IU) capsule
DRUGPlacebo capsule
Placebo one pill only
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.
Exclusion criteria
* Secondary causes of RLS Medications (list included in section C below) iron deficiency or peripheral neuropathy Presence of RLS-mimicking disorders: 1. Arthritis 2. Deep venous thrombosis 3. Varicose veins or venous insufficiency 4. Habitual foot tapping Patients receiving medications that could trigger RLS: 1. Anticonvulsants, e.g., new use of anticonvulsant drugs within6 months of screening. A stable regimen of anticonvulsants was allowed. 2. Antipsychotics (haloperidol or phenothiazine derivatives) 3. Antidepressants (selective serotonin reuptake inhibitors or tricyclic antidepressants) 4. Antimanic (lithium) Patients on medications or with conditions that may interfere with vitamin C & E absorption: 1. Celiac disease 2. Crohn's disease 3. Chronic pancreatitis 4. Cystic fibrosis 5. Weight-reduction drugs 6. Chemotherapy and radiotherapy Patients with contraindications for vitamin C & E supplements: 1. Blood disorders, e.g., thalassemia, G6PD, sickle cell disease and hemochromatosis 2. Other conditions like diabetic patients, oxalate nephropathy, nephrolithiasis and vitamin E or C allergy 3. Unstable vital signs 4. Retinal eye disease 5. Cancers 6. Liver disease 7. Vitamin K deficiency For women only: 1. Pregnancy (positive pregnancy test at screening) 2. Currently breastfeeding 3. Use of oral contraceptives or start of menopausal hormone therapy within 3 months of baseline History of vitamin E or C intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | In screening | Participants will be considered normal if the level is within 6 - 26 umol/L |
| Total Iron Binding Capacity | In screening | Participants will be considered normal if the level is within 25 - 92 umol/L |
| Ferritin | In screening | Participants will be considered normal if the level is within 13-150 ng/ml |
| Magnesium | In screening | Participants will be considered normal if the level is within 1.7 - 2.2 mg/dL |
Contacts
Primary ContactSiraj Wali
Outcome results
None listed