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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
  Purpose

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 Intervention
Thalassemia
Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
Drug: Curcuminoids and alpha-tocopherol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597765

Locations
Thailand
Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
ChaingMai University
Investigators
Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01597765     History of Changes
Other Study ID Numbers: Si 063/2009
Study First Received: May 10, 2012
Last Updated: May 13, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Thalassemia
Oxidative stress
antioxidant cocktail

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Acetylcysteine
Alpha-Tocopherol
Antioxidants
Deferiprone
N-monoacetylcystine
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Anti-Infective Agents
Antidotes
Antiviral Agents
Chelating Agents
Expectorants
Free Radical Scavengers
Growth Substances
Iron Chelating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 20, 2014