The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major

NCT03948737 | Completed DMC

• 1 other identifier: NSovira
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Beta Thalassemia Major Anemia; Hemolysis; Oxidative Stress

Keywords

Haptoglobin; Hemopexin; Hemolysis; Malondialdehyde; Glutathione; Oxidative stress; Alpha-Tocopherol

Outcome Measures

Primary Outcomes (1)

• The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-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 Outcomes (2)

• The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major

  4 weeks

• The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major

  4 weeks

Study Arms (2)

Alpha-Tocopgerol

ACTIVE COMPARATOR

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.

Drug: Alpha-Tocopherol; Drug: Placebo oral tablet

Control

PLACEBO COMPARATOR

Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.

Drug: Alpha-Tocopherol; Drug: Placebo oral tablet

Interventions

Alpha-Tocopherol DRUG

all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.

Also known as: Santa E

Alpha-Tocopgerol; Control

Placebo oral tablet DRUG

Also known as: Alpha-tocopherol placebo

Alpha-Tocopgerol; Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• received frequent transfusions,
• iron chelation
• aged 5 - 18-year-olds
• with no other hematologic disorders
• does not consume any other antioxidants or herbal supplements

You may not qualify if:

• the acute or chronic infection including hepatitis B or hepatitis C,
• splenectomy
• liver failure
• abnormality level of lipid test

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10340, Indonesia

Location

Related Publications (8)

• 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.

  PMID: 29333256 RESULT

• 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.

  PMID: 26285072 RESULT

• 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.

  PMID: 26175690 RESULT

• 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.

  PMID: 23995229 RESULT

• 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.

  PMID: 16506966 RESULT

• 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.

  PMID: 25389409 RESULT

• 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.

  PMID: 15981230 RESULT

• 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.

  PMID: 23105782 RESULT

Related Links

• Drug information of alpha-Tocopherol

MeSH Terms

Conditions

Hemolysis

Interventions

alpha-Tocopherol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pustika Amalia, Consultant

  Hematology Oncologist Head Division of Child Health of Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masking. No any information about treatment or placebo in participant, investigator, care provider and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Beta thalassemia major children

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: December 30, 2016
• Primary Completion: July 30, 2017
• Study Completion: August 1, 2017
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)