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

Thalassemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597765
• Other study ID #: Si 063/2009
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: May 13, 2012
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• beta-Thalassemia
• Thalassemia

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Thailand	Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	ChaingMai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Malonyldiadehyde (MDA)	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	1 year after treatment with antioxidant cocktail.