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Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?

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: NCT03014882
Recruitment Status : Unknown
Verified January 2017 by Alaa Youssef Ahmed, Ain Shams University.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Alaa Youssef Ahmed, Ain Shams University

Study Description
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Brief Summary:

Accumulation of iron in patients with beta thalassemia major causes free radical formation which leads to damage of biological membranes. Sperm DNA damage may result from these generated antioxidants.

We aimed at investigating the current DNA damage in the sperms of adult patients with beta thalassemia major and the effect generated by giving antioxidant treatment for 6 months.


Condition or disease Intervention/treatment Phase
Endocrine Disease Fertility Decreased Male DNA Damage Drug: L-Carnitine and N-acetyl cysteine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sperm DNA Damage in β-thalassemia Major: Is There a Role for Antioxidants?
Study Start Date : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Antioxidant treatment Drug: L-Carnitine and N-acetyl cysteine


Outcome Measures
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Primary Outcome Measures :
  1. DNA fragmentation index [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pubertal patients with beta thalassemia major

Exclusion Criteria:

  • Associated endcrinopathy
Contacts and Locations
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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): NCT03014882


Locations
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Egypt
Ain Shams University Hospitals
Cairo Governorate, Cairo, Egypt, 11566
Ain Shams University
Cairo Governorate, Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Heba H Elsedfy, Professor Ain Shams University
More Information
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Responsible Party: Alaa Youssef Ahmed, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT03014882    
Other Study ID Numbers: Endocrinology PECASU
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Endocrine System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Acetylcysteine
N-monoacetylcystine
 Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes