The Effect of Oral Zinc Supplementation on Thiol Oxido-reductive Index
1 other identifier
interventional
120
1 country
1
Brief Summary
Although several studies have considered the relationship between infertility and semen thiol compounds levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on thiol related enzymes 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
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 7, 2016
CompletedDecember 7, 2016
December 1, 2016
1 year
December 2, 2016
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thiol oxido-reductive index levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Thiol oxido-reductive index levels.
up to three months.
Secondary Outcomes (2)
Glutathione peroxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Glutathione peroxidase activity levels.
up to three months.
Sulfhydryl oxidase activity levels in spermatozoa and seminal plasma. The investigators evaluated the effects of zinc sulfate (220 mg/d) supplementation on Sulfhydryl oxidase activity levels.
up to three months.
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
- mahmoud hussein hadwanlead
- Ministry of Health, Iraqcollaborator
Study Sites (1)
Mahmoud Hadwan
Hillah, Babylon, 51002, Iraq
Related Publications (1)
Alsalman ARS, Almashhedy LA, Hadwan MH. Effect of Oral Zinc Supplementation on the Thiol Oxido-Reductive Index and Thiol-Related Enzymes in Seminal Plasma and Spermatozoa of Iraqi Asthenospermic Patients. Biol Trace Elem Res. 2018 Aug;184(2):340-349. doi: 10.1007/s12011-017-1215-8. Epub 2017 Dec 8.
PMID: 29222649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Hadwan, PhD
Babylon University
- STUDY DIRECTOR
L Almashhedy, PhD
Babylon University
- STUDY CHAIR
Alsalman Abdulrrazaq, PhD
Babylon University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 7, 2016
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
December 7, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
I plan to publish the results in a scientific journal