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

King Abdulaziz University160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

160

Conditions

Restless Legs Syndrome End Stage Renal Disease

Interventions

Ascorbic acidDRUG

vitamin C (200 mg) capsule

TocopherolDRUG

vitamin E (400 IU) capsule

Placebo capsuleDRUG

Placebo one pill only

Placebo capsule

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: in screening

Hemoglobin

Participants with normal levels between 12 - 15 g/dl Participants with levels below 12 or above 15 will be considered abnormal

Time frame: 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.

Time frame: 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

Central Contacts

Siraj Wali

CONTACT

0966505606100 sowali@kau.edu.sa

Data from ClinicalTrials.gov

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