Oxidative Stress Clinical Trial
Official title:
The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell
Verified date | May 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patient. By this randomized controlled trial, the investigators would like to evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 1, 2017 |
Est. primary completion date | July 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
Inclusion Criteria: - received frequent transfusions, - iron chelation - aged 5 - 18-year-olds - with no other hematologic disorders - does not consume any other antioxidants or herbal supplements Exclusion Criteria: - the acute or chronic infection including hepatitis B or hepatitis C, - splenectomy - liver failure - abnormality level of lipid test |
Country | Name | City | State |
---|---|---|---|
Indonesia | Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Körmöczi GF, Säemann 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. — View Citation
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: 10.103 — View Citation
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. Re — View Citation
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. Review. — View Citation
Voskou S, Aslan M, Fanis P, Phylactides M, Kleanthous M. Oxidative stress in ß-thalassaemia and sickle cell disease. Redox Biol. 2015 Dec;6:226-239. doi: 10.1016/j.redox.2015.07.018. Epub 2015 Aug 1. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effects of a-tocopherol in hemolysis marker on the red cell membrane of ß-thalassemia major | The plasma haptoglobin and hemolysis as hemolysis marker on alpha-tocopherol treatment were assessed by ELISA using Haptoglobin and Hemopexin kit for human | 4 weeks | |
Secondary | The effects of a-tocopherol in oxidative stress marker on the red cell membrane of ß-thalassemia major | The malondialdehyde plasma level as oxidative stress marker on alpha-tocopherol treatment was assessed by Spectrophotometry using TBARS method. | 4 weeks | |
Secondary | The effects of a-tocopherol in endogenous antioxidant on the red cell membrane of ß-thalassemia major | The Glutathione as endogenous antioxidant marker on alpha-tocopherol treatment was assessed by ELISA method by using GT40 for Glutathione kit | 4 weeks |
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