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NCT Number: NCT03948737

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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10340, Indonesia

About this study

Background: 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 patients.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Santa E

Placebo oral tablet

Drug

Other names: Alpha-tocopherol placebo

Primary outcomes

  1. The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major

    Time frame: 4 weeks

    The plasma haptoglobin and hemolysis as hemolysis marker on alpha-tocopherol treatment were assessed by ELISA using Haptoglobin and Hemopexin kit for human

Secondary outcomes

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

    Time frame: 4 weeks

    The malondialdehyde plasma level as oxidative stress marker on alpha-tocopherol treatment was assessed by Spectrophotometry using TBARS method.

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

    Time frame: 4 weeks

    The Glutathione as endogenous antioxidant marker on alpha-tocopherol treatment was assessed by ELISA method by using GT40 for Glutathione kit

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 14, 2019
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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