The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major
NCT ID: NCT03948737
Last Updated: 2019-05-14
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-12-30
2017-08-01
Brief Summary
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Detailed Description
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Purpose: To evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.
Methods: In this randomized controlled trial, the investigators allocated subjects in the placebo and α-tocopherol groups. Doses of α-tocopherol were based on the recommendation of Institute of Medicine: 4-8 years old 200 mg/day; 9-13 years old 400 mg/day; 14-18 years old 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4 weeks of consuming either α-tocopherol or placebo, performed prior to blood transfusions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alpha-Tocopgerol
Alpha-Tocopherol supplementation will be given orally for 4 weeks with doses adjusted by age.
5-8 years old: 200 mg daily, 9-13 years old: 400 mg daily and 14-18 years old 600 mg daily.
Alpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Placebo oral tablet
Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
Alpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Placebo oral tablet
Interventions
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Alpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Placebo oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* iron chelation
* aged 5 - 18-year-olds
* with no other hematologic disorders
* does not consume any other antioxidants or herbal supplements
Exclusion Criteria
* splenectomy
* liver failure
* abnormality level of lipid test
5 Years
18 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Nora Sovira
Principal Investigator
Principal Investigators
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Pustika Amalia, Consultant
Role: PRINCIPAL_INVESTIGATOR
Hematology Oncologist Head Division of Child Health of Universitas Indonesia
Locations
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Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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Fibach E, Rachmilewitz EA. Pathophysiology and treatment of patients with beta-thalassemia - an update. F1000Res. 2017 Dec 20;6:2156. doi: 10.12688/f1000research.12688.1. eCollection 2017.
Voskou S, Aslan M, Fanis P, Phylactides M, Kleanthous M. Oxidative stress in beta-thalassaemia and sickle cell disease. Redox Biol. 2015 Dec;6:226-239. doi: 10.1016/j.redox.2015.07.018. Epub 2015 Aug 1.
Smith A, McCulloh RJ. Hemopexin and haptoglobin: allies against heme toxicity from hemoglobin not contenders. Front Physiol. 2015 Jun 30;6:187. doi: 10.3389/fphys.2015.00187. eCollection 2015.
Schaer CA, Deuel JW, Bittermann AG, Rubio IG, Schoedon G, Spahn DR, Wepf RA, Vallelian F, Schaer DJ. Mechanisms of haptoglobin protection against hemoglobin peroxidation triggered endothelial damage. Cell Death Differ. 2013 Nov;20(11):1569-79. doi: 10.1038/cdd.2013.113. Epub 2013 Aug 30.
Kormoczi GF, Saemann MD, Buchta C, Peck-Radosavljevic M, Mayr WR, Schwartz DW, Dunkler D, Spitzauer S, Panzer S. Influence of clinical factors on the haemolysis marker haptoglobin. Eur J Clin Invest. 2006 Mar;36(3):202-9. doi: 10.1111/j.1365-2362.2006.01617.x.
Schaer DJ, Vinchi F, Ingoglia G, Tolosano E, Buehler PW. Haptoglobin, hemopexin, and related defense pathways-basic science, clinical perspectives, and drug development. Front Physiol. 2014 Oct 28;5:415. doi: 10.3389/fphys.2014.00415. eCollection 2014.
Chow J, Phelan L, Bain BJ. Evaluation of single-tube osmotic fragility as a screening test for thalassemia. Am J Hematol. 2005 Jul;79(3):198-201. doi: 10.1002/ajh.20387.
Ghone RA, Kumbar KM, Suryakar AN, Katkam RV, Joshi NG. Oxidative stress and disturbance in antioxidant balance in beta thalassemia major. Indian J Clin Biochem. 2008 Oct;23(4):337-40. doi: 10.1007/s12291-008-0074-7. Epub 2008 Dec 20.
Provided Documents
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Document Type: Study Protocol
Related Links
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Drug information of alpha-Tocopherol
Other Identifiers
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NSovira
Identifier Type: -
Identifier Source: org_study_id
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