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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948737
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Nora Sovira, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Anemia Hemolysis Oxidative Stress Drug: Alpha-Tocopherol Drug: Placebo oral tablet Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Beta thalassemia major children
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double masking. No any information about treatment or placebo in participant, investigator, care provider and outcome assessor
Primary Purpose: Treatment
Official Title: The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell
Actual Study Start Date : December 30, 2016
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : August 1, 2017


Arm Intervention/treatment
Active Comparator: 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.

Drug: Alpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Other Name: Santa E

Drug: Placebo oral tablet
Other Name: Alpha-tocopherol placebo

Placebo Comparator: Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
Drug: Alpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Other Name: Santa E

Drug: Placebo oral tablet
Other Name: Alpha-tocopherol placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948737


Locations
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Indonesia
Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo
Jakarta Pusat, Jakarta, Indonesia, 10340
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Pustika Amalia, Consultant Hematology Oncologist Head Division of Child Health of Universitas Indonesia
  Study Documents (Full-Text)

Documents provided by Nora Sovira, Indonesia University:
Study Protocol  [PDF] November 30, 2016


Additional Information:
Publications of Results:

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Responsible Party: Nora Sovira, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03948737    
Other Study ID Numbers: NSovira
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nora Sovira, Indonesia University:
Haptoglobin
Hemopexin
Hemolysis
Malondialdehyde
Glutathione
Oxidative stress
Alpha-Tocopherol
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Hemolysis
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pathologic Processes
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances