Status:
UNKNOWN
The Effect of Vitamin C and E Therapy on Restless Leg Syndrome in Patients With End Stage Renal Disease on Haemodialysis
Lead Sponsor:
King Abdulaziz University
Conditions:
Restless Legs Syndrome
End Stage Renal Disease
Eligibility:
All Genders
Phase:
PHASE3
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 diagno...
Eligibility Criteria
Inclusion
- End stage renal disease patients on hemodialysis who met the five diagnostic criteria of RLS.
Exclusion
- Secondary causes of RLS Medications (list included in section C below) iron deficiency or peripheral neuropathy
- Presence of RLS-mimicking disorders:
- Arthritis
- Deep venous thrombosis
- Varicose veins or venous insufficiency
- Habitual foot tapping
- Patients receiving medications that could trigger RLS:
- Anticonvulsants, e.g., new use of anticonvulsant drugs within6 months of screening. A stable regimen of anticonvulsants was allowed.
- Antipsychotics (haloperidol or phenothiazine derivatives)
- Antidepressants (selective serotonin reuptake inhibitors or tricyclic antidepressants)
- Antimanic (lithium)
- Patients on medications or with conditions that may interfere with vitamin C \& E absorption:
- Celiac disease
- Crohn's disease
- Chronic pancreatitis
- Cystic fibrosis
- Weight-reduction drugs
- Chemotherapy and radiotherapy
- Patients with contraindications for vitamin C \& E supplements:
- Blood disorders, e.g., thalassemia, G6PD, sickle cell disease and hemochromatosis
- Other conditions like diabetic patients, oxalate nephropathy, nephrolithiasis and vitamin E or C allergy
- Unstable vital signs
- Retinal eye disease
- Cancers
- Liver disease
- Vitamin K deficiency
- For women only:
- Pregnancy (positive pregnancy test at screening)
- Currently breastfeeding
- Use of oral contraceptives or start of menopausal hormone therapy within 3 months of baseline
- History of vitamin E or C intolerance
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05350124
Start Date
November 1 2022
End Date
December 1 2023
Last Update
August 24 2022
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