Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
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|ClinicalTrials.gov Identifier: NCT01061320|
Recruitment Status : Unknown
Verified January 2010 by Thammasat University.
Recruitment status was: Enrolling by invitation
First Posted : February 3, 2010
Last Update Posted : February 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Contrast Induced Nephropathy||Drug: alpha tocopherol Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||December 2010|
|Active Comparator: alpha tocopherol||
Drug: alpha tocopherol
The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
Other Name: Bio-E-vitamin
|Placebo Comparator: placebo||
The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.
Other Name: jelly
- The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. [ Time Frame: 1 year ]
- The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061320
|Khlong Luang, Pathumtani, Thailand, 12121|
|Principal Investigator:||Adis Tasanarong, MD||Faculty of Medicine, Thammasat University (Rangsit Campus)|