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Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients

NCT01125033 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-06-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.

Conditions

  • Restless Legs Syndrome
  • Kidney Failure, Chronic

Interventions

DRUG

Vitamin C & Vitamin E

The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks

DRUG

Vitamin C

The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.

DRUG

Vitamin E

The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.

DRUG

Vitamin C Placebo & Vitamin E Placebo

The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Hamideh Akbari, MD · Shiraz University of Medical Sciences

  • Mohammad Mahdi Sagheb, MD · Shiraz University of Medical Sciences

  • Sahar Sohrabi Nazari, MD · Shiraz University of Medical Sciences

  • Mohammad Kazem Fallahzadeh, MD · Shiraz University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125033 on ClinicalTrials.gov