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

Sponsored by King Abdulaziz University

About this trial

Last updated 3 years ago

Study ID

VIT.C&E RLS on HM

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial 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

What are the participation requirements?

Yes

Inclusion Criteria

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

No

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