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Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

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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

Tracking Information
First Submitted Date  ICMJE May 10, 2012
First Posted Date  ICMJE May 14, 2012
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Official Title  ICMJE Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Curcuminoids
    The administrate curcuminoids is intervention for 30 patients
    Interventions:
    • Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
    • Drug: Curcuminoids and alpha-tocopherol
  • Experimental: Vitamin E
    The vitamin E is intervention for 30 patients
    Interventions:
    • Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
    • Drug: Curcuminoids and alpha-tocopherol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2012)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01597765
Other Study ID Numbers  ICMJE Si 063/2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE ChaingMai University
Investigators  ICMJE
Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr. Mahidol University
PRS Account Mahidol University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP