Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers
1 other identifier
interventional
120
1 country
1
Brief Summary
Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been reported.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 6, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedFebruary 3, 2017
February 1, 2017
11 months
August 6, 2014
February 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxido-sensitive index level in spermatozoa and seminal plasma.
up to three months.
Secondary Outcomes (6)
Volume of semen.
up to three months.
Xanthine oxidase activity in spermatozoa and seminal plasma.
up to three months.
Catalase like activity in spermatozoa and seminal plasma.
up to three months.
Superoxide dismutase activity in spermatozoa and seminal plasma.
up to three months.
Progressive sperm motility percentage.
up to three months
- +1 more secondary outcomes
Study Arms (2)
Zinc sulfate
EXPERIMENTAL60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
Healthy control
NO INTERVENTION60 fertile (age 31.6±3.3 year) men, no treatment.
Interventions
The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
Eligibility Criteria
You may qualify if:
- the presence of asthenozoospermia in the semen sample.
You may not qualify if:
- the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Babylon Universitylead
- Ministry of Health, Iraqcollaborator
Study Sites (1)
Babylon University
Hillah, Babylon, 51002, Iraq
Related Publications (1)
Hadwan MH, Almashhedy LA, Alsalman AR. Oral Zinc Supplementation Restores Superoxide Radical Scavengers to Normal Levels in Spermatozoa of Iraqi Asthenospermic Patients. Int J Vitam Nutr Res. 2015;85(3-4):165-73. doi: 10.1024/0300-9831/a000235.
PMID: 26780395DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud H. Hadwan, PhD
Babylon University/ Iraq
- STUDY DIRECTOR
Lamia A. Almashhedy, PhD
Babylon University/ Iraq
- STUDY CHAIR
Abdulrrazaq S. Alsalman, PhD
Babylon University/ Iraq
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mahmoud Hussein Hadwan
Study Record Dates
First Submitted
August 6, 2014
First Posted
August 15, 2014
Study Start
July 1, 2011
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
February 3, 2017
Record last verified: 2017-02