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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01597765

Enrollment

Registered

2012-05-14

Start date

2009-06-30

Completion date

2011-06-30

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia

Keywords

Thalassemia, Oxidative stress, antioxidant cocktail

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.

Interventions

DRUGcurcuminoids, 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

DRUGCurcuminoids 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026