NCT05350124

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ascorbic acid	vitamin C (200 mg) capsule
DRUG	Tocopherol	vitamin E (400 IU) capsule
DRUG	Placebo capsule	Placebo one pill only
DRUG	Placebo capsule	Placebo two pills only

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-04-27
• Last updated: 2022-08-24