The effect of vitamin D supplementation on androgen hormones, sperm motility, and morphology in patients with sperm motility disorder and vitamin D deficiency.
The aim of this study was to evaluate the effect of vitamin D supplementation on androgen hormones, sperm motility, and morphology in patients with sperm motility disorder and vitamin D deficiency.
Design
In this study, 44 patients are chosen who have inclusion criteria. participant were randomly allocated to two intervention and placebo groups and given code to each of theme.
Settings and conduct
A randomized double-blind clinical trial was conducted in men with sperm motility disorder who referred to Research Institute for Reproductive science.
Participants/Inclusion and exclusion criteria
inclusion criteria: The desire to participate in the study - men aged 20-45 years old - Passing for at least one year from the time you decide to have a baby and not use contraceptives - sperm motility disorder according to WHO criteria - Not using vitamin D supplements and calcium in the last 3 months- levels of 25 hydroxyvitamin D (25OHD) less than 30 ng / ml
exclusion criteria: unwillingness to participate - Having varicocele - individuals with azoospermia, cryptorchidism, and microorchidism - History of vasectomy
Intervention groups
In this study, 44 men with sperm motility disorder are selected and entered into the study according to inclusion criteria, and divided into two groups of 22 responders receiving placebo. The participants will be randomized using statistical package for social sciences (SPSS) to receive either vitamin D or placebo supplementation that is identical in terms of appearance, taste colour.
Main outcome variables
sperm motility, morphology and concentration, total testosterone, SHBG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120913010826N29
Registration date:2018-04-29, 1397/02/09
Registration timing:registered_while_recruiting
Last update:2018-04-29, 1397/02/09
Update count:0
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2017-10-16, 1396/07/24
Expected recruitment end date
2018-10-16, 1397/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on androgen hormones, sperm motility, and morphology in patients with sperm motility disorder and vitamin D deficiency.
Public title
The effect of vitamin D supplementation in people with sperm motility disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study - men aged 20-45 years old - Passing for at least one year from the time that decide to have a baby and not use contraceptives - sperm motility disorder according to WHO criteria - Not using vitamin D supplements and calcium in the last 3 months- levels of 25 hydroxyvitamin D (25OHD) less than 30 ng / ml
Exclusion criteria:
unwillingness to participate - Having varicocele - individuals with azoospermia, cryptorchidism, and microorchidism - History of vasectomy
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Using the randomized code obtained from the SPSS
Blinding (investigator's opinion)
Double blinded
Blinding description
Prescribing supplement and placebo by a researcher without knowledge of its type, as well as taking it by the participants in the study without their
knowledge. In order to minimize bias in the intervention, one researcher randomly assigns random access to the patient in a randomized manner, without any knowledge of the patient's condition, and the other investigator who is associated with the patient, will place that person in the designated group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-08-06, 1396/05/15
Ethics committee reference number
IR.SSU.SPH.REC.1396.87
Health conditions studied
1
Description of health condition studied
asthenozoospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
sperm motility
Timepoint
Before and after intervention
Method of measurement
Semen sample
2
Description
Total testosterone
Timepoint
Before and after intervention
Method of measurement
Blood sample
3
Description
Sex hormone binding globulin
Timepoint
Before and after intervention
Method of measurement
Blood sample
4
Description
Free androgen index
Timepoint
Before and after intervention
Method of measurement
Total testosterone / SHBG
5
Description
Sperm morphology
Timepoint
Before and after intervention
Method of measurement
Semen sample
6
Description
sperm concentration
Timepoint
Before and after intervention
Method of measurement
Semen sample
Secondary outcomes
1
Description
Body Fat percent
Timepoint
Before and after intervention
Method of measurement
by body composition analyzer
2
Description
Weight
Timepoint
Before and after intervention
Method of measurement
by body composition analyzer
3
Description
Body mass index
Timepoint
Before and after intervention
Method of measurement
kg/m2
4
Description
Muscle mass percent
Timepoint
Before and after intervention
Method of measurement
by body composition analyzer
5
Description
waist circumference
Timepoint
Before and after intervention
Method of measurement
Meter
6
Description
hip circumference
Timepoint
Before and after intervention
Method of measurement
Meter
7
Description
vitamin D
Timepoint
Before and after intervention
Method of measurement
blood sample
Intervention groups
1
Description
In the intervention group, a dose of 50,000 units of vitamin D was administered for 12 weeks (one perl of vitamin D per week for 8 weeks and only one perl of vitamin d administered as a maintenance dose in the last 4 weeks)
Category
Treatment - Drugs
2
Description
In the control group, placebo was administered for 12 weeks (one placebo per week for 8 weeks and only one placebo administered in the last 4 weeks)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute of Reproductive Sciences
Full name of responsible person
Azadeh Nadjarzadeh
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadnajarzadeh@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hoshangh Mehrparvar
Street address
Yazd, shohadaye gomnam Blvd, Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Gheflati
Position
MSc student of public nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
آدرس خیابان Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
Email
alireza.2130@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azadeh Najarzadeh
Position
PhD in Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Safaeieh, shohadaye gomnam Blvd, Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
Email
azadehnajarzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Alireza Gheflati
Position
MSc student of public nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
Email
alireza.2130@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data report will be shared after publishing the paper.
When the data will become available and for how long
Six months after publish
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Using for Meta-analysis
From where data/document is obtainable
Center nutrition, public health, univercity of medical sciencies yazd Tel: 009835 31492239 Email: azadehnajarzadeh@gmail.com Azadenadjarzadeh
What processes are involved for a request to access data/document
It will be sent two weeks after the receipt of the email with the consent of the co-workers