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

May 13, 2012 updated by: Mahidol University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year after treatment with antioxidant cocktail.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

ChaingMai University

Investigators

  • Study Chair: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr., Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 14, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 13, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 063/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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