Clinical trial NCT05350124: The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis
Official title: The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Restless Legs Syndrome
End Stage Renal Disease
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria
timeFrame: in screening
measure: Stop Bang
timeFrame: in screening
measure: Hemoglobin
timeFrame: in screening
measure: 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
measure: Epworth sleepiness scale (ESS)
timeFrame: base line then once every 4 weeks for 12 weeks
measure: Medical Outcomes Study Sleep Scale (MOS)
timeFrame: base line then once every 4 weeks for 12 weeks
measure: Suggested Immobilization Test (SIT)
timeFrame: base line then once every 4 weeks for 12 weeks
measure: Restless Leg Syndrome (RLS) Symptoms Diary
timeFrame: base line then daily for the last 2 weeks
measure: Polysomnography
timeFrame: base line then once every 4 weeks for 12 weeks
measure: Hemoglobin A1C
timeFrame: In screening
measure: Vitamin D
timeFrame: In screening
measure: Serum Iron
timeFrame: In screening
measure: Total Iron Binding Capacity
timeFrame: In screening
measure: Ferritin
timeFrame: In screening
measure: Magnesium
timeFrame: In screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: