| Trial ID: | L1482 |
| Source ID: | NCT01125033
|
| Associated Drug: |
Vitamin C & Vitamin E
|
| Title: |
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
|
| Acronym: |
ShirazUMS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Restless Legs Syndrome|Kidney Failure, Chronic
|
| Interventions: |
DRUG: Vitamin C & Vitamin E|DRUG: Vitamin C|DRUG: Vitamin E|DRUG: Vitamin C Placebo & Vitamin E Placebo
|
| Outcome Measures: |
Primary: Absolute Change in IRLS Sum Score, Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population, 8 Weeks | Secondary: Number of participants with adverse events, Number of participants with adverse events throughout the treatment phase of the study would be assessed., 8 Weeks
|
| Sponsor/Collaborators: |
Sponsor: Shiraz University of Medical Sciences
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-03
|
| Completion Date: |
2009-02
|
| Results First Posted: |
|
| Last Update Posted: |
2011-06-17
|
| Locations: |
Shiraz University of Medical Sciences, Shiraz, Fars, Iran, Islamic Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01125033
|
