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

NCT01597765 — Not applicable, Completed, 60 participants, Mahidol University

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Registry	NCT01597765
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Mahidol University (Other); collaborators: Chiang Mai University
Conditions	Thalassemia
Interventions	curcuminoids, N-acetylcysteine, deferiprone and vitamin E, Curcuminoids and alpha-tocopherol (Drug)
Dates	start 2009-06-01, primary completion 2011-06-01, completion 2011-06-01, first posted 2012-05-14, last updated 2012-05-15
Locations	1 site in Thailand

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Curcuminoids	Experimental	Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Drug: Curcuminoids and alpha-tocopherol	The administrate curcuminoids is intervention for 30 patients
Vitamin E	Experimental	Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Drug: Curcuminoids and alpha-tocopherol	The vitamin E is intervention for 30 patients

curcuminoids, N-acetylcysteine, deferiprone and vitamin E (Drug), also known as 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: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
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

+Outcome measures

Primary outcomes

Malonyldiadehyde (MDA) [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

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university	Bangkoknoi, Bangkok	Thailand

+Investigators

Ruchaneekorn Kalpravidh, Assoc. Prof. Dr., Study chair, Mahidol University