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

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03014882
• Collaborator: (none)
• Enrollment: 30
• Locations: 3
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Feb 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Antioxidant treatment	Drug: L-Carnitine and N-acetyl cysteine

Outcome Measures

Primary Outcome Measures

1. DNA fragmentation index [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pubertal patients with beta thalassemia major

Exclusion Criteria:

• Associated endcrinopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo Governorate	Cairo	Egypt	11566
2	Ain Shams University	Cairo Governorate		Egypt
3	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Youssef Ahmed, Dr, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03014882
• Other Study ID Numbers: Endocrinology PECASU
• First Posted: Jan 9, 2017
• Last Update Posted: Jan 9, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Thalassemia; beta-Thalassemia; Endocrine System Diseases; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Jan 9, 2017