Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
1 other identifier
observational
60
1 country
1
Brief Summary
The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via lipid peroxidation, the induction of oxidative DNA damage and the formation of protein adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO synthases. Several studies suggest that the overproduction of this free radical and the subsequent excessive exposure to oxidative conditions have a potential pathogenetic implication, which due to the reduction of sperm motility. The present study was conducted to study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of patients with asthenozoospmia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2011
Shorter than P25 for all trials
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
September 9, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedSeptember 12, 2012
September 1, 2012
1 year
September 9, 2012
September 11, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Nitric oxide synthase activity
at the end of three months
Secondary Outcomes (1)
Arginase activity
at the end of three months
Study Arms (1)
Single group
Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)
Interventions
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
Eligibility Criteria
this study includes 60 fertile male partners from couples who had consulted the infertility clinic of babil hospital of maternity (Hilla city/ IRAQ).
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/ college of science
Hillah, Hilla, IQ, Iraq
Related Publications (1)
Hadwan MH, Almashhedy LA, Alsalman AR. Study of the effects of oral zinc supplementation on peroxynitrite levels, arginase activity and NO synthase activity in seminal plasma of Iraqi asthenospermic patients. Reprod Biol Endocrinol. 2014 Jan 3;12:1. doi: 10.1186/1477-7827-12-1.
PMID: 24383664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mahmoud H. hadwan, phD
babylon university / Iraq
- STUDY CHAIR
Lamia A. Almashhedy, phD
Babylon university/Iraq
- STUDY DIRECTOR
abdulrrazaq S. Alsalman, phD
Babylon university/Iraq
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- phD
Study Record Dates
First Submitted
September 9, 2012
First Posted
September 12, 2012
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
September 12, 2012
Record last verified: 2012-09