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Completed

NCT Number: NCT01597765

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18-50 years
  • hemoglobin level between 6-9 g/dL during screen visit
  • WHO performance status grade 0-2
  • signed in informed consents prior to the study entry.

Exclusion criteria

  • receiving iron chelator and blood transfusion.
  • pregnancy or breastfeeding
  • receiving other drugs except folic acid at least 30 days before study.

Treatment and study plan

curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Drug

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

Curcuminoids and alpha-tocopherol

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Chiang Mai University

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 14, 2012
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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