Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

Sponsor
Babylon University (Other)
Overall Status
Completed
CT.gov ID
NCT03361618
Collaborator
Ministry of Health, Iraq (Other)
120
1
2
11
10.9

Study Details

Study Description

Brief Summary

Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Zinc Sulfate
N/A

Detailed Description

The present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Semen volume after treatment.Semen volume after treatment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway in Spermatozoa and Seminal Plasma of Iraqi Asthenospermic Patients
Actual Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zinc sulfate

60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Dietary Supplement: Zinc Sulfate
The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

No Intervention: Healthy control

60 fertile (age 31.6±3.3 year) men, no treatment.

Outcome Measures

Primary Outcome Measures

  1. Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer. [up to three months.]

    Clinical parameter

Secondary Outcome Measures

  1. Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer. [up to three months.]

    Enzyme

  2. Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer. [up to three months.]

    Enzyme

  3. Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer. [up to three months.]

    Enzyme

Eligibility Criteria

Criteria

Ages Eligible for Study:
26 Years to 36 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • The presence of asthenozoospermia in the semen sample.

  • Must be unable to reproduce.

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

Locations

Site City State Country Postal Code
1 Mahmoud Hussein Hadwan Hilla Babylon Iraq 51002

Sponsors and Collaborators

  • Babylon University
  • Ministry of Health, Iraq

Investigators

  • Study Chair: Abdul Razzaq A. Alsalman, PhD, University of Babyblon
  • Study Director: Lamia A. Almashhedy, PhD, University of Babyblon
  • Principal Investigator: Mahmoud Hussein Hadwan, PhD, University of Babyblon
  • Study Director: Abdulsamie H Alta'ee, PhD, University of Babyblon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mahmoud hussein hadwan, Principal Investigator Dr. Mahmoud Hussein Hadwan, Babylon University
ClinicalTrials.gov Identifier:
NCT03361618
Other Study ID Numbers:
  • Babil-5
First Posted:
Dec 5, 2017
Last Update Posted:
Dec 5, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by mahmoud hussein hadwan, Principal Investigator Dr. Mahmoud Hussein Hadwan, Babylon University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2017