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Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Thammasat University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Drug: alpha tocopherol Drug: placebo Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Arm Intervention/treatment
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 Drug: 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

Primary Outcome Measures :
  1. The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)

Exclusion Criteria:

  • patients with acute kidney injury
  • end stage renal disease (requiring dialysis)
  • unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study)
  • allergy to any of the contrast agents
  • mechanical ventilation
  • suffered from congestive heart failure, cardiogenic shock or emergent angiography.
  • receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT01061320

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Adis Tasanarong
Khlong Luang, Pathumtani, Thailand, 12121
Sponsors and Collaborators
Thammasat University
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Principal Investigator: Adis Tasanarong, MD Faculty of Medicine, Thammasat University (Rangsit Campus)

Additional Information:
Publications of Results:
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Responsible Party: Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus) Identifier: NCT01061320     History of Changes
Other Study ID Numbers: MTU-I-1-53/52
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: January 2010
Keywords provided by Thammasat University:
Alpha-Tocopherol (Vitamin E)
Contrast induced nephropathy
Chronic kidney disease
Coronary procedures
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents