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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Investigator)
  • Study Primary Completion Date: June 2011

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Experimental: Curcuminoids
    • The administrate curcuminoids is intervention for 30 patients
  • Experimental: Vitamin E
    • The vitamin E is intervention for 30 patients

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Collaborator
    • Chiang Mai University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ruchaneekorn Kalpravidh, Assoc. Prof. Dr., Study Chair, Mahidol University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.