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Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E 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.
 
ClinicalTrials.gov Identifier: NCT01597765
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : May 15, 2012
Sponsor:
Collaborator:
ChaingMai University
Information provided by (Responsible Party):
Mahidol University

Study Description
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Brief Summary:
The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E Drug: Curcuminoids and alpha-tocopherol Not Applicable

Detailed Description:
60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Curcuminoids
The administrate curcuminoids is intervention for 30 patients
 Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
Other Names:
  • curcuminoids 500 mg brand name Anti-Ox
  • N-acetylcysteine 200 mg brand name Mysoven
  • deferiprone 50 mg/kg/day brand name GPO-L-ONE
  • vitamin E 400 IU/day brand name Natural

Drug: Curcuminoids and alpha-tocopherol
group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day
Experimental: Vitamin E
The vitamin E is intervention for 30 patients
 Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
Other Names:
  • curcuminoids 500 mg brand name Anti-Ox
  • N-acetylcysteine 200 mg brand name Mysoven
  • deferiprone 50 mg/kg/day brand name GPO-L-ONE
  • vitamin E 400 IU/day brand name Natural

Drug: Curcuminoids and alpha-tocopherol
group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day


Outcome Measures
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Primary Outcome Measures :
  1. Malonyldiadehyde (MDA) [ Time Frame: 1 year after treatment with antioxidant cocktail. ]
    Lipid peroxidation will be assayed by measuring the formation of malonyldialdehyde (MDA). The formation of MDA on red blood cell will be exposed by hydrogen peroxide. Then, MDA will be extracted by trichloroacetic acid (TCA) and will be reacted with thiobarbituric acid (TBA) in boiling condition to MDA-TBAR complex. This complex will be given pink color and measuring at 532 and 600 nm


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age between 18-50 years
  2. hemoglobin level between 6-9 g/dL during screen visit
  3. WHO performance status grade 0-2
  4. signed in informed consents prior to the study entry.

Exclusion Criteria:

  1. receiving iron chelator and blood transfusion.
  2. pregnancy or breastfeeding
  3. receiving other drugs except folic acid at least 30 days before study.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01597765


Locations
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Thailand
Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
ChaingMai University
Investigators
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Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr. Mahidol University
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01597765    
Other Study ID Numbers: Si 063/2009
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Mahidol University:
Thalassemia
Oxidative stress
antioxidant cocktail
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Acetylcysteine
N-monoacetylcystine
 Deferiprone
Micronutrients
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes
Iron Chelating Agents
Chelating Agents
Sequestering Agents