- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684059
Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
September 11, 2012 updated by: mahmoud hussein hadwan, Babylon University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous studies suggest that high concentrations of NO play an injurious consequence on spermatozoa kinetic characteristics.
These studies reported that NO may react with superoxide or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins.
NO also may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes, aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine triphosphate and that is due to loss of motility of spermatozoa.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hilla, Iraq, IQ
- Babylon university/ college of science
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
27 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
this study includes 60 fertile male partners from couples who had consulted the infertility clinic of babil hospital of maternity (Hilla city/ IRAQ).
Description
Inclusion Criteria:
- the presence of asthenozoospermia in the semen sample.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single group
Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)
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every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Nitric oxide synthase activity
Time Frame: at the end of three months
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at the end of three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Arginase activity
Time Frame: at the end of three months
|
at the end of three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
September 9, 2012
First Submitted That Met QC Criteria
September 11, 2012
First Posted (Estimate)
September 12, 2012
Study Record Updates
Last Update Posted (Estimate)
September 12, 2012
Last Update Submitted That Met QC Criteria
September 11, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Babil-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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