Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 14, 2012
CompletedMay 15, 2012
May 1, 2012
2 years
May 10, 2012
May 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Curcuminoids
EXPERIMENTALThe administrate curcuminoids is intervention for 30 patients
Vitamin E
EXPERIMENTALThe vitamin E is intervention for 30 patients
Interventions
receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- receiving iron chelator and blood transfusion.
- pregnancy or breastfeeding
- receiving other drugs except folic acid at least 30 days before study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mahidol Universitylead
- Chiang Mai Universitycollaborator
Study Sites (1)
Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ruchaneekorn Kalpravidh, Assoc. Prof. Dr.
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 14, 2012
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 15, 2012
Record last verified: 2012-05