NCT03014882

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2015

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

January 6, 2017

Last Update Submit

January 6, 2017

Conditions

Endocrine DiseaseFertility Decreased MaleDNA Damage

Outcome Measures

Primary Outcomes (1)

  • DNA fragmentation index

    6 months

Study Arms (1)

Antioxidant treatment

OTHER
Drug: L-Carnitine and N-acetyl cysteine

Interventions

L-Carnitine and N-acetyl cysteineDRUG
Antioxidant treatment

Eligibility Criteria

Age16 Years+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pubertal patients with beta thalassemia major

You may not qualify if:

  • Associated endcrinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ain Shams University Hospitals

Cairo Governorate, Cairo Governorate, 11566, Egypt

Location

Ain Shams University

Cairo, Egypt

Location

Ain Shams University

Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

CarnitineAcetylcysteine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsCysteineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Heba H Elsedfy, Professor

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 9, 2017

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

EG(3)