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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

Tracking Information
First Submitted Date September 9, 2012
First Posted Date September 12, 2012
Last Update Posted Date September 12, 2012
Study Start Date July 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2012)
Nitric oxide synthase activity [ Time Frame: at the end of three months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 11, 2012)
Arginase activity [ Time Frame: at the end of three months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
Official Title Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway
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.
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
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Asthenozoospermia
Intervention Dietary Supplement: zinc sulfate
every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
Study Groups/Cohorts Single group
Single group: each participant receive same intervention (zinc sulfate) throughout study (non-randomized)
Intervention: Dietary Supplement: zinc sulfate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2012)
60
Original Actual Enrollment Same as current
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 27 Years to 35 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iraq
Removed Location Countries  
 
Administrative Information
NCT Number NCT01684059
Other Study ID Numbers Babil-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party mahmoud hussein hadwan, Babylon University
Study Sponsor Babylon University
Collaborators Ministry of Health, Iraq
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
PRS Account Babylon University
Verification Date September 2012