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

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

Sponsors

Lead Sponsor: Indonesia University

Source 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.

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.

Overall Status Completed
Start Date December 30, 2016
Completion Date August 1, 2017
Primary Completion Date July 30, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major 4 weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Alpha-Tocopherol

Description: 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

Intervention Type: Drug

Intervention Name: Placebo oral tablet

Other Name: Alpha-tocopherol placebo

Eligibility

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pustika Amalia, Consultant Principal Investigator Hematology Oncologist Head Division of Child Health of Universitas Indonesia
Location
Facility: Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo
Location Countries

Indonesia

Verification Date

May 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Indonesia University

Investigator Full Name: Nora Sovira

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Alpha-Tocopgerol

Type: Active Comparator

Description: 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.

Label: Control

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Beta thalassemia major children

Primary Purpose: Treatment

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

Source: ClinicalTrials.gov