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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdulaziz University
• Treatments: Ascorbic Acid; Tocopherols; Vitamin E; Vitamins

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