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

This study has been completed.
Sponsor:
Collaborator:
ChaingMai University
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01597765
First received: May 10, 2012
Last updated: May 13, 2012
Last verified: May 2012

May 10, 2012
May 13, 2012
June 2009
June 2011   (final data collection date for primary outcome measure)
Malonyldiadehyde (MDA) [ Time Frame: 1 year after treatment with antioxidant cocktail. ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01597765 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Thalassemia
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01597765
Si 063/2009
Yes
Mahidol University
Mahidol University
ChaingMai University
Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr. Mahidol University
Mahidol University
May 2012

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