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

Primary Purpose

Thalassemia

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Curcuminoids and alpha-tocopherol

About this trial

This is an interventional treatment trial for Thalassemia focused on measuring Thalassemia, Oxidative stress, antioxidant cocktail

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age between 18-50 years
hemoglobin level between 6-9 g/dL during screen visit
WHO performance status grade 0-2
signed in informed consents prior to the study entry.

Exclusion Criteria:

receiving iron chelator and blood transfusion.
pregnancy or breastfeeding
receiving other drugs except folic acid at least 30 days before study.

Sites / Locations

Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Curcuminoids

Vitamin E

Arm Description

The administrate curcuminoids is intervention for 30 patients

The vitamin E is intervention for 30 patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01597765

First Posted

May 10, 2012

Last Updated

May 13, 2012

Sponsor

Mahidol University

Collaborators

ChaingMai University

1. Study Identification

Unique Protocol Identification Number

NCT01597765

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

Collaborators

ChaingMai University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thalassemia

Keywords

Thalassemia, Oxidative stress, antioxidant cocktail

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcuminoids

Arm Type

Experimental

Arm Description

The administrate curcuminoids is intervention for 30 patients

Arm Title

Vitamin E

Arm Type

Experimental

Arm Description

The vitamin E is intervention for 30 patients

Intervention Type

Drug

Intervention Name(s)

curcuminoids, N-acetylcysteine, deferiprone and vitamin E

Other Intervention Name(s)

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

Intervention Description

receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day

Intervention Type

Drug

Intervention Name(s)

Curcuminoids and alpha-tocopherol

Intervention Description

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

Primary Outcome Measure Information:

Title

Malonyldiadehyde (MDA)

Description

Time Frame

1 year after treatment with antioxidant cocktail.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 18-50 years hemoglobin level between 6-9 g/dL during screen visit WHO performance status grade 0-2 signed in informed consents prior to the study entry. Exclusion Criteria: receiving iron chelator and blood transfusion. pregnancy or breastfeeding receiving other drugs except folic acid at least 30 days before study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruchaneekorn Kalpravidh, Assoc. Prof. Dr.

Organizational Affiliation

Mahidol University

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

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

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