Vitamin D DeficiencyNCT03477136
Serum and Semen Vitamin D Level With Semen Parameters
An observational study of Vitamin D Deficiency, run by Assiut University at 1 site in Egypt.
Trial summary
vitamin D may have multiple functions, one of them is modulating reproductive processes and the reproductive role of vitamin D is highlighted by expression of the vitamin D receptors in testis, male reproductive tract and sperms Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- ELISA to evaluate serum and seminal vitamin D level
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2018to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: The patients will be recruited from the out patient clinic of Andrology, Assuit university hospital. One hundred and fifty individuals will be included divided into five groups according to semen parameters finding
Who may be able to join
- -males with different semen parameter finding
- Age: 20-50 years
Who cannot join
- Varicocele.
- Genital tract infections.
- Primary and secondary hypogonadism
- Hormonal therapy.
- Calcium and vitamin D supplement.
- Hepatic or renal failure
- Diseases or drugs affecting vitamin D absorption -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males
vitamin D may have multiple functions, one of them is modulating reproductive processes and the reproductive role of vitamin D is highlighted by expression of the vitamin D receptors in testis, male reproductive tract and sperms
Read the detailed description
Semen analysis is the corner stone of infertility evaluation as it provides information on the functional status of the seminiferous tubules, epididymis and accessory sex glands. The methods on how the semen should be evaluated are provided by the World Health Organization Vitamin D is synthesized mainly in the skin, where ultraviolet ray B radiation converts 7-dehydrocholesterol to Vitamin D3. Then, Vitamin D3 undergoes two hydroxylation processes first in the liver and second in the kidney Serum 25(OH)D is the major circulating metabolite of vitamin D and reflects vitamin D inputs from cutaneous synthesis and dietary intake. The serum 25(OH)D level is the standard clinical measure of vitamin D status Vitamin D deficiency has been linked to various health disorders including boneheallth, cardiovascular, infectious, oncologic, musculoskeletal, neuropsychologic and reproductive disorders, as well as to overall mortality
- Conditions
- Vitamin D Deficiency
- Being tested
- ELISA to evaluate serum and seminal vitamin D level
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA to evaluate serum and seminal vitamin D levelDiagnostic test
Also called semen analysis
Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen
| Study group | Role | What they receive |
|---|---|---|
| First group: semen parameter showing normospermic | * group will include 30 male
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
* blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . Receives: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level | |
| second group: semen parameter asthenozoospermic | * group will include 30 male
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
* blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . Receives: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level | |
| Third group: semen parameter oligozoospermic | * group will include 30 male
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
* blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . Receives: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level | |
| Forth groupsemen parameter: astheno-teratozoospermic, | * group will include 30 male
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
* blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . Receives: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level | |
| Fifth group semen parameter: oligo asthenoteratozoospermia | * group will include 30 male
* Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
* blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . Receives: Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of serum and semen vitamin D level with semen parameters in males
evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters
Measured: A year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start6 Dec 2018
- Primary completion13 Jul 2020
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Yonan, Assiut University
- Investigators
- Mary Younan, Resident, Principal investigator, Assiut Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477136
- Sponsor's protocol ID
- SSVDSS
- Status last verified
- Jul 2020
- First submitted
- 20 Mar 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blomberg Jensen M, Jorgensen A, Nielsen JE, Bjerrum PJ, Skalkam M, Petersen JH, Egeberg DL, Bangsboll S, Andersen AN, Skakkebaek NE, Juul A, Rajpert-De Meyts E, Dissing S, Leffers H, Jorgensen N. Expression of the vitamin D metabolizing enzyme CYP24A1 at the annulus of human spermatozoa may serve as a novel marker of semen quality. Int J Androl. 2012 Aug;35(4):499-510. doi: 10.1111/j.1365-2605.2012.01256.x. Epub 2012 Mar 9.
PubMed 22404291Esteves SC. Clinical relevance of routine semen analysis and controversies surrounding the 2010 World Health Organization criteria for semen examination. Int Braz J Urol. 2014 Jul-Aug;40(4):443-53. doi: 10.1590/S1677-5538.IBJU.2014.04.02.
PubMed 25254609Hammoud AO, Meikle AW, Peterson CM, Stanford J, Gibson M, Carrell DT. Association of 25-hydroxy-vitamin D levels with semen and hormonal parameters. Asian J Androl. 2012 Nov;14(6):855-9. doi: 10.1038/aja.2012.77. Epub 2012 Oct 8.
PubMed 23042450Herrmann M, Farrell CL, Pusceddu I, Fabregat-Cabello N, Cavalier E. Assessment of vitamin D status - a changing landscape. Clin Chem Lab Med. 2017 Jan 1;55(1):3-26. doi: 10.1515/cclm-2016-0264.
PubMed 27362963Yan WJ, Yu N, Yin TL, Liu L, Yang J. Can Vitamin D supplementation be used as adjunctive treatment for oligozoospermia or asthenozoospermia accompanied with Vitamin D deficiency? Asian J Androl. 2015 Jan-Feb;17(1):165-7. doi: 10.4103/1008-682X.138190. No abstract available.
PubMed 25219916
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum and Semen Vitamin D Level With Semen Parameters in Males
- ClinicalTrials.gov ID
- NCT03477136
- Acronym / sponsor ID
- SSVDSS
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
vitamin D may have multiple functions, one of them is modulating reproductive processes and the reproductive role of vitamin D is highlighted by expression of the vitamin D receptors in testis, male reproductive tract and sperms
Detailed description
Semen analysis is the corner stone of infertility evaluation as it provides information on the functional status of the seminiferous tubules, epididymis and accessory sex glands. The methods on how the semen should be evaluated are provided by the World Health Organization Vitamin D is synthesized mainly in the skin, where ultraviolet ray B radiation converts 7-dehydrocholesterol to Vitamin D3. Then, Vitamin D3 undergoes two hydroxylation processes first in the liver and second in the kidney Serum 25(OH)D is the major circulating metabolite of vitamin D and reflects vitamin D inputs from cutaneous synthesis and dietary intake. The serum 25(OH)D level is the standard clinical measure of vitamin D status Vitamin D deficiency has been linked to various health disorders including boneheallth, cardiovascular, infectious, oncologic, musculoskeletal, neuropsychologic and reproductive disorders, as well as to overall mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| First group: semen parameter showing normospermic | – | Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level* group will include 30 male * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) * blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . |
| second group: semen parameter asthenozoospermic | – | Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level* group will include 30 male * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) * blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . |
| Third group: semen parameter oligozoospermic | – | Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level* group will include 30 male * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) * blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . |
| Forth groupsemen parameter: astheno-teratozoospermic, | – | Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level* group will include 30 male * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) * blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . |
| Fifth group semen parameter: oligo asthenoteratozoospermia | – | Diagnostic Test: ELISA to evaluate serum and seminal vitamin D level* group will include 30 male * Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010) * blood and semen sample will be collected from all males to evaluate vitamin D level by ELISA . |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients will be recruited from the out patient clinic of Andrology, Assuit university hospital. One hundred and fifty individuals will be included divided into five groups according to semen parameters finding
Key inclusion criteria (2 listed)
- -males with different semen parameter finding
- Age: 20-50 years
Key exclusion criteria (7 listed)
- Varicocele.
- Genital tract infections.
- Primary and secondary hypogonadism
- Hormonal therapy.
- Calcium and vitamin D supplement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA to evaluate serum and seminal vitamin D levelAlso: semen analysisSerum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen | Diagnostic test | Fifth group semen parameter: oligo asthenoteratozoospermia, First group: semen parameter showing normospermic, Forth groupsemen parameter: astheno-teratozoospermic,, Third group: semen parameter oligozoospermic, second group: semen parameter asthenozoospermic |
Primary outcome
correlation of serum and semen vitamin D level with semen parameters in males
Time frame: A year
evaluation the level of vitamin D in serum and semen by using ELISA method and correlate it with semen parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 22404291Blomberg Jensen M, Jorgensen A, Nielsen JE, Bjerrum PJ, Skalkam M, Petersen JH, Egeberg DL, Bangsboll S, Andersen AN, Skakkebaek NE, Juul A, Rajpert-De Meyts E, Dissing S, Leffers H, Jorgensen N. Expression of the vitamin D metabolizing enzyme CYP24A1 at the annulus of human spermatozoa may serve as a novel marker of semen quality. Int J Androl. 2012 Aug;35(4):499-510. doi: 10.1111/j.1365-2605.2012.01256.x. Epub 2012 Mar 9.
- Background: PubMed 25254609Esteves SC. Clinical relevance of routine semen analysis and controversies surrounding the 2010 World Health Organization criteria for semen examination. Int Braz J Urol. 2014 Jul-Aug;40(4):443-53. doi: 10.1590/S1677-5538.IBJU.2014.04.02.
- Background: PubMed 23042450Hammoud AO, Meikle AW, Peterson CM, Stanford J, Gibson M, Carrell DT. Association of 25-hydroxy-vitamin D levels with semen and hormonal parameters. Asian J Androl. 2012 Nov;14(6):855-9. doi: 10.1038/aja.2012.77. Epub 2012 Oct 8.
- Background: PubMed 27362963Herrmann M, Farrell CL, Pusceddu I, Fabregat-Cabello N, Cavalier E. Assessment of vitamin D status - a changing landscape. Clin Chem Lab Med. 2017 Jan 1;55(1):3-26. doi: 10.1515/cclm-2016-0264.
- Background: PubMed 25219916Yan WJ, Yu N, Yin TL, Liu L, Yang J. Can Vitamin D supplementation be used as adjunctive treatment for oligozoospermia or asthenozoospermia accompanied with Vitamin D deficiency? Asian J Androl. 2015 Jan-Feb;17(1):165-7. doi: 10.4103/1008-682X.138190. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Younan, Resident principal investigator
Assiut Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of serum and semen vitamin D level with semen parameters in males (time frame: A year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03477136, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.