Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202304634296590 Date of Approval: 04/04/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of zinc supplementation on semen parameters, serum and seminal zinc levels of oligozoospermic men attending University of Ilorin Teaching Hospital (UITH): A randomized double - blind trial.
Official scientific title The effect of zinc supplementation on semen parameters, serum and seminal zinc levels of oligozoospermic men attending University of Ilorin Teaching Hospital (UITH): A randomized double - blind trial.
Brief summary describing the background and objectives of the trial Zinc plays an important role in testicular development, spermatogenesis, sperm quality and sperm motility. Several studies on adult males with zinc deficiency showed that synthesis of testosterone and spermatogenesis may be as a result of adequate dietary supplementation of zinc. There are conflicting reports about the role of zinc supplementation in the improvement of sperm quality. While some studies demonstrated improved semen quality, others showed it is ineffective. Furthermore, available evidence is also inconclusive regarding the effect of zinc supplementation on seminal and serum zinc levels. General Objectives To determine the effect of zinc supplementation on semen parameters, serum zinc level and seminal zinc level of men with oligozoospermia. Specific objectives To review literature on zinc levels, semen parameters and male sub-fertility. To determine the baseline serum and seminal zinc levels among oligozoopermic men. To determine the baseline other semen parameters of oligozoospermic men. To compare seminal and serum zinc levels of oligozoospermic men on zinc supplements with those receiving placebo. To compare the post treatment semen parameters, among oligozoospermic men on zinc supplementation with those receiving placebo. To make recommendations based on findings from objectives 2, 3, 4 and 5.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/02/2022
Actual trial start date 14/02/2022
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Zinc Sulfate 25mg of elemental zinc Three(3)months Each participant in the Intervention group will take 25mg of elemental zinc daily over three months 41
Control Group Inactive drug Daily Three (3) months Placebo which is an inactive drug containing maize starch will be taken daily for three months 41 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male partners of infertile couple within the age of 20-59years having regular unprotected intercourse for a year or more. 2. Men with sperm concentration <15million cells/ml on two occasions 4 weeks apart. 3. Male partners with normal descended testes. 4. Patient who consent to participate in the study 1. Men with the following problems will be exckuded:Aspermia, azoospermia, testicular varicocele, ongoing sexually transmitted disease, chronic illness, serious systemic disease like diabetes, endocrine and metabolic disorders, smoking, alcohol intake and previous groin or scrotal surgery 2. Men that have used zinc within three months of recruitment /other supplements 3. Men on drugs that suppress spermatogenesis such as steroidsand other immunosuppressive drugs 4. Men with immunosuppressive disease like Human Immunodeficiency Virus (HIV) and malignancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 59 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/05/2022 University of Ilorin Teaching Hospital Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road, Oke Ose Ilorin 240102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Baseline seminal and serum zinc levels 2. Serum and seminal zinc level after administration of zinc sulphate or placebo. 3. Baseline sperm count 4. Sperm count after administration of zinc sulphate or placebo Pre-Intervention and post-Intervention
Secondary Outcome 1. Semen parameters (Concentration, motility, morphology and volume) after administration of zinc sulphate and placebo. 2. Adverse effects of the Intervention drug reported by the patients. Post-Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Old Jebba Road, Oke Ose Ilorin 240102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Salary Old Jebba Road Ilorin 240102 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sadiya Musa Gwadabe Old Jebba Road Ilorin 240102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sadiya Gwadabe mgsadiya@yahoo.com +2347069448106 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin 240102 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Kike Adesina teminikike@yahoo.com +2348033813442 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin 240102 Nigeria Consultant Obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Sherifat Tinuke Suleiman sherifat.suleiman@npmcn.edu.ng +2348032520227 Old Jebba Road
City Postal code Country Position/Affiliation
Ilorin 240102 Nigeria Consultant Medical Microbiology and Parasitology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients participate in this trial/research would not be individually identified in the reports or publication that will arise from the study. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan It should be available within twelve (12) month of completion of the study Oligozoospermia, semen parameters, serum zinc, semen zinc, zinc sulphate
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information