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Vitamin C and Vitamin E for RLS in Hemodialysis Patients
NCT01125033Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2008
- Primary completion
- Jan 2009
- Countries
- 1
- Sponsor
- Shiraz University of Medical Sciences
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- restless legs syndrome (RLS)
01
Overview
Phase 3, randomised, double-blind trial of ascorbic acid and vitamin e in restless legs syndrome (RLS) (4 arms), sponsored by Shiraz University of Medical Sciences. Primary endpoint: Absolute Change in International Restless Legs Syndrome (IRLS) Sum Score at 8 weeks. Started Mar 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Vitamin C + Vitamin E
Vitamin C (200 mg) + Vitamin E (400 mg) daily
Vitamin C + Placebo
Vitamin C (200 mg) + Placebo daily
Vitamin E + Placebo
Vitamin E (400 mg) + Placebo daily
Placebo + Placebo
Double Placebo daily
03
Endpoints
Primary
Absolute Change in International Restless Legs Syndrome (IRLS) Sum Score
Secondary
Number of participants with adverse events
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