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

This study has been completed.
Sponsor:
Collaborator:
Ministry of health/Iraq
Information provided by (Responsible Party):
mahmoud hussein hadwan, Babylon University
ClinicalTrials.gov Identifier:
NCT01684059
First received: September 9, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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 Intervention
Asthenozoospermia
Dietary Supplement: zinc sulfate

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study the Effect of Oral Zinc Supplementation on Enzymes of Nitric Oxide Pathway

Resource links provided by NLM:


Further study details as provided by Babylon University:

Primary Outcome Measures:
  • Nitric oxide synthase activity [ Time Frame: at the end of three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Arginase activity [ Time Frame: at the end of three months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   27 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684059

Locations
Iraq
Babylon university/ college of science
Hilla, Iraq, IQ
Sponsors and Collaborators
Babylon University
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
  More Information

No publications provided by Babylon University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: mahmoud hussein hadwan, phD, Babylon University
ClinicalTrials.gov Identifier: NCT01684059     History of Changes
Other Study ID Numbers: Babil-2
Study First Received: September 9, 2012
Last Updated: September 11, 2012
Health Authority: Iraq: Ethics Committee

Additional relevant MeSH terms:
Asthenozoospermia
Genital Diseases, Male
Infertility
Infertility, Male
Nitric Oxide
Zinc
Zinc Sulfate
Anti-Asthmatic Agents
Antioxidants
Astringents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Dermatologic Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Gasotransmitters
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Trace Elements
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014