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

NCT05350124 | Unknown Phase 3

• 1 other identifier: VIT.C&E RLS on HM
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Conditions

Restless Legs Syndrome; End Stage Renal Disease

Outcome Measures

Primary Outcomes (15)

• 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

  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

  in screening

• Hemoglobin

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

  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.

  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

  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.

  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

  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

  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

  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

  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

  In screening

• Serum Iron

  Participants will be considered normal if the level is within 6 - 26 umol/L

  In screening

• Total Iron Binding Capacity

  Participants will be considered normal if the level is within 25 - 92 umol/L

  In screening

• Ferritin

  Participants will be considered normal if the level is within 13-150 ng/ml

  In screening

• Magnesium

  Participants will be considered normal if the level is within 1.7 - 2.2 mg/dL

  In screening

Study Arms (4)

Group 1

EXPERIMENTAL

Vitamin C (200 mg) capsule, and vitamin E (400 IU) capsule every day for 12 weeks.

Drug: Ascorbic acid; Drug: Tocopherol

Group 2

EXPERIMENTAL

Vitamin C (200 mg) capsule, and placebo every day for 12 weeks.

Drug: Ascorbic acid; Drug: Placebo capsule

Group 3

EXPERIMENTAL

Vitamin E (400 IU) capsule, and placebo every day for 12 weeks.

Drug: Tocopherol; Drug: Placebo capsule

Group 4

EXPERIMENTAL

Placebo capsule (2 pills) every day for 12 weeks.

Drug: Placebo capsule

Interventions

Ascorbic acid DRUG

vitamin C (200 mg) capsule

Also known as: Vitamin C

Group 1; Group 2

Tocopherol DRUG

vitamin E (400 IU) capsule

Also known as: Vitamin E

Group 1; Group 3

Placebo capsule DRUG

Placebo one pill only

Also known as: Inactive substance

Group 2; Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Restless Legs Syndrome; Kidney Failure, Chronic

Interventions

Ascorbic Acid; Tocopherols; Vitamin E

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Siraj Wali

CONTACT

0966505606100; sowali@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Sleep Medicine and research center

Model Details: 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 Record Dates

• First Submitted: March 17, 2022
• First Posted: April 27, 2022
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share