ThalassemiaNCT01597765
Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
A study testing curcuminoids, N-acetylcysteine, deferiprone and vitamin E and Curcuminoids and alpha-tocopherol in people with Thalassemia, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Thalassemia
- What is being tested?
- curcuminoids, N-acetylcysteine, deferiprone and vitamin E and Curcuminoids and alpha-tocopherol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- receiving iron chelator and blood transfusion.
- pregnancy or breastfeeding
- receiving other drugs except folic acid at least 30 days before study.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university
Bangkoknoi, Bangkok, 10700
About this study
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.
Read the 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.
- Conditions
- Thalassemia
- Being tested
- curcuminoids, N-acetylcysteine, deferiprone and vitamin E, Curcuminoids and alpha-tocopherol
- Keywords
- Thalassemia, Oxidative stress, antioxidant cocktail
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminoids, N-acetylcysteine, deferiprone and vitamin EDrug
Also called 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
receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
Curcuminoids and alpha-tocopherolDrug
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 group | Role | What they receive |
|---|---|---|
| Curcuminoids | Experimental | The administrate curcuminoids is intervention for 30 patients Receives: Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Drug: Curcuminoids and alpha-tocopherol |
| Vitamin E | Experimental | The vitamin E is intervention for 30 patients Receives: Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E; Drug: Curcuminoids and alpha-tocopherol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after treatment with antioxidant cocktail.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University
- Responsible party
- Sponsor
- Investigators
- Ruchaneekorn Kalpravidh, Assoc. Prof. Dr., Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597765
- Sponsor's protocol ID
- Si 063/2009
- Status last verified
- May 2012
- First submitted
- 10 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
- ClinicalTrials.gov ID
- NCT01597765
- Acronym / sponsor ID
- Si 063/2009
- Conditions
- Thalassemia
- Keywords
- Thalassemia, Oxidative stress, antioxidant cocktail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Chiang Mai University
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcuminoids | Experimental | Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E, Drug: Curcuminoids and alpha-tocopherolThe administrate curcuminoids is intervention for 30 patients |
| Vitamin E | Experimental | Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E, Drug: Curcuminoids and alpha-tocopherolThe vitamin E is intervention for 30 patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- receiving iron chelator and blood transfusion.
- pregnancy or breastfeeding
- receiving other drugs except folic acid at least 30 days before study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcuminoids, N-acetylcysteine, deferiprone and vitamin EAlso: 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 Naturalreceiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day | Drug | Curcuminoids, Vitamin E |
| Curcuminoids and alpha-tocopherolgroup 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 | Drug | Curcuminoids, Vitamin E |
Primary outcome
Malonyldiadehyde (MDA)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchaneekorn Kalpravidh, Assoc. Prof. Dr. study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcuminoids, N-acetylcysteine, deferiprone and vitamin E and Curcuminoids and alpha-tocopherol in people with Thalassemia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malonyldiadehyde (MDA) (time frame: 1 year after treatment with antioxidant cocktail.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.