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

• ClinicalTrials.gov Identifier: NCT03014882
• Recruitment Status: Unknown
• First Posted: January 9, 2017
• Last Update Posted: January 9, 2017
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Alaa Youssef Ahmed, Ain Shams University

Tracking Information

• First Submitted Date: January 6, 2017
• First Posted Date: January 9, 2017
• Last Update Posted Date: January 9, 2017
• Study Start Date: February 2015
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 6, 2017): DNA fragmentation index [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Endocrine Disease
• Fertility Decreased Male
• DNA Damage

• Intervention: Drug: L-Carnitine and N-acetyl cysteine

Study Arms

Antioxidant treatment

Intervention: Drug: L-Carnitine and N-acetyl cysteine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 6, 2017): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pubertal patients with beta thalassemia major

Exclusion Criteria:

• Associated endcrinopathy

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03014882
• Other Study ID Numbers: Endocrinology PECASU
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Alaa Youssef Ahmed, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Heba H Elsedfy, Professor; Ain Shams University

• PRS Account: Ain Shams University
• Verification Date: January 2017