Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.
Contrast Induced Nephropathy
Drug: alpha tocopherol
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|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|
- The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|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
Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061320
|Khlong Luang, Pathumtani, Thailand, 12121|
|Principal Investigator:||Adis Tasanarong, MD||Faculty of Medicine, Thammasat University (Rangsit Campus)|