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

NCT ID: NCT05350124

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-12-31

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.

Conditions

Restless Legs Syndrome; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 4

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

Group Type: EXPERIMENTAL

Placebo capsule

Intervention Type: DRUG

Placebo two pills only

Group 1

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

Group Type: EXPERIMENTAL

Ascorbic acid

Intervention Type: DRUG

vitamin C (200 mg) capsule

Tocopherol

Intervention Type: DRUG

vitamin E (400 IU) capsule

Group 2

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

Group Type: EXPERIMENTAL

Ascorbic acid

Intervention Type: DRUG

vitamin C (200 mg) capsule

Placebo capsule

Intervention Type: DRUG

Placebo one pill only

Group 3

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

Group Type: EXPERIMENTAL

Tocopherol

Intervention Type: DRUG

vitamin E (400 IU) capsule

Placebo capsule

Intervention Type: DRUG

Placebo one pill only

Interventions

Ascorbic acid

vitamin C (200 mg) capsule

Intervention Type: DRUG

Tocopherol

vitamin E (400 IU) capsule

Intervention Type: DRUG

Placebo capsule

Placebo one pill only

Intervention Type: DRUG

Placebo capsule

Placebo two pills only

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Vitamin E; Inactive substance; Inactive substance

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Siraj Omar Wali

Head of Sleep Medicine and research center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Siraj Wali

Role: CONTACT

sowali@kau.edu.sa

0966505606100

Other Identifiers

VIT.C&E RLS on HM

Identifier Type: -

Identifier Source: org_study_id