<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684059</url>
  </required_header>
  <id_info>
    <org_study_id>Babil-2</org_study_id>
    <nct_id>NCT01684059</nct_id>
  </id_info>
  <brief_title>Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway</brief_title>
  <official_title>Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babylon University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Iraq</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Babylon University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ability of spermatozoa to produce reactive oxygen species (ROS) has been respected since&#xD;
      the 1940's. Oxidative stress limits the functional competence of mammalian spermatozoa via&#xD;
      lipid peroxidation, the induction of oxidative DNA damage and the formation of protein&#xD;
      adducts. Nitric oxide (NO) is a free radical generated from the oxidation of L-arginine to&#xD;
      L-citrulline by reduced nicotinamide adenine dinucleotide phosphate (NADPH)-dependent NO&#xD;
      synthases. Several studies suggest that the overproduction of this free radical and the&#xD;
      subsequent excessive exposure to oxidative conditions have a potential pathogenetic&#xD;
      implication, which due to the reduction of sperm motility. The present study was conducted to&#xD;
      study the effect of Zn supplementation on the levels of NO synthase and arginase in semen of&#xD;
      patients with asthenozoospmia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies suggest that high concentrations of NO play an injurious consequence on&#xD;
      spermatozoa kinetic characteristics. These studies reported that NO may react with superoxide&#xD;
      or hydrogen peroxide, resulting in the production of peroxinitrite, hydroxyl radical, or&#xD;
      singlet oxygen, which cause oxidation of sperm membrane lipids and thiol proteins. NO also&#xD;
      may inhibit cellular respiration by nitro-sylation of heme in mitochondrial enzymes,&#xD;
      aconitase, and glyceraldehyde phosphate dehydrogenase, leading to a reduction of adenosine&#xD;
      triphosphate and that is due to loss of motility of spermatozoa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nitric oxide synthase activity</measure>
    <time_frame>at the end of three months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arginase activity</measure>
    <time_frame>at the end of three months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Asthenozoospermia</condition>
  <arm_group>
    <arm_group_label>Single group</arm_group_label>
    <description>Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>zinc sulfate</intervention_name>
    <description>every participant took two capsules of zinc sulfate per day for three months (each one 220mg)</description>
    <arm_group_label>Single group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        this study includes 60 fertile male partners from couples who had consulted the infertility&#xD;
        clinic of babil hospital of maternity (Hilla city/ IRAQ).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the presence of asthenozoospermia in the semen sample.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the absence of endocrinopathy,&#xD;
&#xD;
          -  varicocele, and&#xD;
&#xD;
          -  female factor infertility. Smokers and alcoholic men were excluded from the study&#xD;
             because of their recognized high seminal ROS levels and decreased antioxidant levels&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>27 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mahmoud H. hadwan, phD</last_name>
    <role>Principal Investigator</role>
    <affiliation>babylon university / Iraq</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lamia A. Almashhedy, phD</last_name>
    <role>Study Chair</role>
    <affiliation>Babylon university/Iraq</affiliation>
  </overall_official>
  <overall_official>
    <last_name>abdulrrazaq S. Alsalman, phD</last_name>
    <role>Study Director</role>
    <affiliation>Babylon university/Iraq</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Babylon university/ college of science</name>
      <address>
        <city>Hilla</city>
        <zip>IQ</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Babylon University</investigator_affiliation>
    <investigator_full_name>mahmoud hussein hadwan</investigator_full_name>
    <investigator_title>phD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthenozoospermia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zinc Sulfate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684059
org study id: Babil-2
nct id: NCT01684059
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Case-Control
time perspective: Retrospective
measure: Nitric oxide synthase activity
time frame: at the end of three months
measure: Arginase activity
time frame: at the end of three months
arm group label: Single group
description: Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)
intervention type: Dietary Supplement
intervention name: zinc sulfate
description: every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
arm group label: Single group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 27 Years
maximum age: 35 Years
healthy volunteers: No
last name: mahmoud H. hadwan, phD
role: Principal Investigator
affiliation: babylon university / Iraq
last name: Lamia A. Almashhedy, phD
role: Study Chair
affiliation: Babylon university/Iraq
last name: abdulrrazaq S. Alsalman, phD
role: Study Director
affiliation: Babylon university/Iraq
facility: 
country: Iraq
responsible party type: Principal Investigator
investigator affiliation: Babylon University
investigator full name: mahmoud hussein hadwan
investigator title: phD
mesh term: Asthenozoospermia
mesh term: Zinc Sulfate