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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03014882
• Other study ID #: Endocrinology PECASU
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: January 6, 2017
• Last updated: January 6, 2017
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ethical Committee Ain Shams University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Pubertal patients with beta thalassemia major

Exclusion Criteria:

• Associated endcrinopathy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• beta-Thalassemia
• DNA Damage
• Endocrine Disease
• Endocrine System Diseases
• Fertility Decreased Male
• Thalassemia

Intervention

Drug:
• L-Carnitine and N-acetyl cysteine

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo
Egypt	Ain Shams University	Cairo Governorate
Egypt	Ain Shams University Hospitals	Cairo Governorate	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA fragmentation index		6 months	No