ShirazUMS
Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
February 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 2009
Actual (reported)February 2009
Actual (reported)May 14, 2010
Actual (reported)May 18, 2010
Actual (reported)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
Number of participants with adverse events
8 Weeks
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
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
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
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
Shiraz University of Medical Sciences
Shiraz, Fars, Iran
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
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
60 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2010
First Posted
May 18, 2010
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Vitamin K 2 on Vascular Calcification in Hemodialysis Patients
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Linked from the registry description. Each source intervention is retained as reported.
In: Vitamin C & Vitamin E
In: Vitamin C & Vitamin E
Contact the study team to confirm eligibility.
Primary Completion
January 2009
Actual (reported)Study Completion
February 2009
Actual (reported)Last Updated
June 17, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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