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

King Abdulaziz University

Status and phase: Not yet enrolling; Phase 3

Conditions: End Stage Renal Disease; Restless Legs Syndrome

Treatments: Drug: Ascorbic acid; Drug: Placebo capsule; Drug: Tocopherol

Study type: Interventional

Funder types: Other

Identifiers

NCT05350124

VIT.C&E RLS on HM

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Tocopherol

Drug: Ascorbic acid

Group 2

Experimental group

Description:

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

Treatment:

Drug: Placebo capsule

Drug: Ascorbic acid

Drug: Placebo capsule

Group 3

Experimental group

Description:

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

Treatment:

Drug: Tocopherol

Drug: Placebo capsule

Drug: Placebo capsule

Group 4

Experimental group

Description:

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

Treatment:

Drug: Placebo capsule

Drug: Placebo capsule