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

Mahidol University

Status: Completed

Conditions: Thalassemia

Treatments: Drug: Curcuminoids and alpha-tocopherol; Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT01597765

Si 063/2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Curcuminoids

Experimental group

Description:

The administrate curcuminoids is intervention for 30 patients

Treatment:

Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Drug: Curcuminoids and alpha-tocopherol

Vitamin E

Experimental group

Description:

The vitamin E is intervention for 30 patients

Treatment:

Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Drug: Curcuminoids and alpha-tocopherol