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Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway

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ClinicalTrials.gov Identifier: NCT01684059
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Collaborator:
Ministry of Health, Iraq
Information provided by (Responsible Party):
mahmoud hussein hadwan, Babylon University

Study Description
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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.

Condition or disease Intervention/treatment
Asthenozoospermia Dietary Supplement: zinc sulfate

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Single group
Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)
 Dietary Supplement: zinc sulfate
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)


Outcome Measures
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Primary Outcome Measures :
  1. Nitric oxide synthase activity [ Time Frame: at the end of three months ]

Secondary Outcome Measures :
  1. Arginase activity [ Time Frame: at the end of three months ]

Eligibility Criteria
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Ages Eligible for Study:   27 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684059


Locations
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Iraq
Babylon university/ college of science
Hilla, Iraq, IQ
Sponsors and Collaborators
Babylon University
Ministry of Health, Iraq
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: mahmoud hussein hadwan, phD, Babylon University
ClinicalTrials.gov Identifier: NCT01684059    
Other Study ID Numbers: Babil-2
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Asthenozoospermia
Infertility, Male
Infertility
Zinc Sulfate
 Astringents
Physiological Effects of Drugs
Dermatologic Agents