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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Thalassemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Curcuminoids

The administrate curcuminoids is intervention for 30 patients

Group Type EXPERIMENTAL

curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Intervention Type DRUG

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

Intervention Type 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

Vitamin E

The vitamin E is intervention for 30 patients

Group Type EXPERIMENTAL

curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Intervention Type DRUG

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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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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

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes