Study of the Effects of Vitamin E and Gabapentin on Restless Legs Syndrome in Hemodialysis Patients

Comparison of the therapeutic effect of vitamin E and gabapentin in restless leg syndrome in ESRD patients undergoing hemodialysis in Chaharmahal Bakhtiari province

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250505065600N1

Enrollment

105

Registered

2025-09-12

Start date

2025-12-22

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome (RLS). Restless legs syndrome

Interventions

Intervention 1: The intervention consists of Vitamin E capsules (400 IU) from Jalinus Pharmaceutical Company. Participants will take one capsule orally, nightly, 2 hours before bedtime, for 8 weeks. V

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients undergoing regular hemodialysis Minimum age: 18 years Diagnosis of Restless Legs Syndrome (RLS)

Exclusion criteria

Exclusion criteria: Renal transplant recipients Individuals receiving pharmacological agents with potential to aggravate Restless Legs Syndrome, including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), dopamine receptor antagonists (e.g., antiemetic agents), lithium salts, and sedative-class antihistamines Patients with underlying chronic disorders that are associated with secondary Restless Legs Syndrome, including rheumatoid arthritis, Parkinson’s disease, individuals prescribed gabapentin or vitamin E for unrelated conditions, acutely hospitalized patients, and those receiving treatment for advanced anemia

Design outcomes

Primary

Measure	Time frame
Severity of sympotms of Restless Legs Syndrome. Timepoint: The severity of restless legs syndrome will be assessed at baseline (prior to initiation of the intervention) and at the end of the eighth week following completion of the intervention. Method of measurement: International Restless Legs Syndrome Study Group (IRLSSG) questionnaire.	—

Secondary

Measure	Time frame
Sleep Quality. Timepoint: Sleep quality will be assessed at baseline (prior to initiation of the intervention) and at the end of the eighth week following completion of the intervention. Method of measurement: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid jafari

Shahre-kord University of Medical Sciences

m.jafari@skums.ac.ir+98 38 3222 8485

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026