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

Not Applicable

Completed

• Conditions: Thalassemia
• Interventions: Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Drug: Curcuminoids and alpha-tocopherol

• Registration Number: NCT01597765
• Lead Sponsor: Mahidol University

Brief 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.

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 Timeline

• Study Start: 2009-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Last Update Submitted: 2012-05-13
• Study First Posted: 2012-05-14
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin E	curcuminoids, N-acetylcysteine, deferiprone and vitamin E	The vitamin E is intervention for 30 patients
Vitamin E	Curcuminoids and alpha-tocopherol	The vitamin E is intervention for 30 patients
Curcuminoids	curcuminoids, N-acetylcysteine, deferiprone and vitamin E	The administrate curcuminoids is intervention for 30 patients
Curcuminoids	Curcuminoids and alpha-tocopherol	The administrate curcuminoids is intervention for 30 patients

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university; 🇹🇭 Bangkoknoi, Bangkok, Thailand