Erectile DysfunctionNCT03867929
Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In present study, we aimed to investigate the association between erectile function severity of serum 25-Hydroxyvitamin-D and cut-off level to treat men with erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- 25-Hydroxy vitamin D
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Sep 2020
- How long will I take part?
- 15 Months
- 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 18 to 80 years
- Men only
- Adult, Older adult
Study population: patients with erectile dysfunction aged between 18 and 80 years
Who may be able to join
- presence of erectile dysfunction
Who cannot join
- Presence of uncontrolled diabetes mellitus,
- Presence of uncontrolled hypertension,
- Presence of uncontrolled lipid metabolism disorders,
- Presence of neurological diseases,
- Presence of heamatological diseases,
- Urinary tract infection,
Show all 12Show fewer
- Diagnosis of any malignencies,
- Chronic kidney failure,
- Presence of metabolic syndrome,
- Presence of psychiatric diseases and/or medical treatment,
- Smoking,
- History of pelvic surgery, cardiac surgery and pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
In present study, we aimed to investigate the association between erectile function severity of serum 25-Hydroxyvitamin-D and cut-off level to treat men with erectile dysfunction.
Read the detailed description
Investigators retrospectively analysed 130 patients admitted to the complaint of erectile dysfunction between aged between 18-80 years old from June 2017 to October 2018 at Cigli Region Training Hospital Urology department and Recep Tayyip Erdogan University Urology Department. International index of erectile function-5 (IIEF-5) Turkish validated short form quesstionaire was performed to all patients. Antropometric characteristics including weight, height, waist circumference, body mass index (BMI) and presence of comorbide diseases were recorded. After detailed history and physical examination performed all patients, overnight fasting in the morning between 08:00-10:00, blood samples from antecubital vein were performed and serum glucose, lipid profile, follicular stimulating hormon (FSH), Luteinizing hormone (LH), total testosterone, prolactin, estradiol, 25(OH)D level were analysed. Presence of uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled lipid metabolism disorders, neurological diseases, heamatological diseases, urinary tract infection, malignencies, chronic kidney failure, metabolic syndrome, psychiatric diseases and/or medical treatment, smoking, history of pelvic surgery, cardiac surgery and pelvic radiotherapy were accepted as exclusion criterias from the study. After IIEF-5 score adjust as 21 point, ROC analyse was used to calculate the cut-off value of 25(OH)D and level of 27.32 ng/mL was calculated as cut-off value. Patients were divided into two group according to 27.32 ng/mL level as a cut off value. Serum 25(OH)D level was lower than 27.32 ng/mL in group 1 (severe and moderate symptomatic group) and higher than 27.32 ng/mL in group 2 (mild symptomatic group).
- Conditions
- Erectile Dysfunction
- Being tested
- 25-Hydroxy vitamin D
- Keywords
- Erectile dysfunction, Vitamin-D, Hypogonadism, Endothelial Dysfunction, Nitric Oxide
- Medical subject headings
- Erectile Dysfunction, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25-Hydroxy vitamin DOther
27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency
| Study group | Role | What they receive |
|---|---|---|
| STUDY | Patient with serum 25-Hydroxy vitamin D level <27.32 Receives: Other: 25-Hydroxy vitamin D | |
| CONTROL | Patient with serum 25-Hydroxy vitamin D level >27.32 Receives: Other: 25-Hydroxy vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory results
Serum 25 Hydroxy vitamin D levels (ng/mL), group 1 include patients with serum 25 hydroxy vitamin D levels higher than 27.32 ng/ml and Group 2 include patients with serum 25 hydroxy vitamin D levels lower than 27.32 ng/mL
Measured: 1 year
Clinical results
IIEF-5 quesstionaire score (0-15 point is severe erectile dysfunction, 16-21 point is moderate erectile dysfunction and >21 point is mild erectile dysfunction)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start1 Jun 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 130 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Mustafa Ozan Horsanalı, Dr., Principal investigator, Cigli Regional Training Hospital, Urology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867929
- Sponsor's protocol ID
- 2
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03867929
- Acronym / sponsor ID
- 2
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile dysfunction, Vitamin-D, Hypogonadism, Endothelial Dysfunction, Nitric Oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 8 Mar 2019 (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.
In present study, we aimed to investigate the association between erectile function severity of serum 25-Hydroxyvitamin-D and cut-off level to treat men with erectile dysfunction.
Detailed description
Investigators retrospectively analysed 130 patients admitted to the complaint of erectile dysfunction between aged between 18-80 years old from June 2017 to October 2018 at Cigli Region Training Hospital Urology department and Recep Tayyip Erdogan University Urology Department. International index of erectile function-5 (IIEF-5) Turkish validated short form quesstionaire was performed to all patients. Antropometric characteristics including weight, height, waist circumference, body mass index (BMI) and presence of comorbide diseases were recorded. After detailed history and physical examination performed all patients, overnight fasting in the morning between 08:00-10:00, blood samples from antecubital vein were performed and serum glucose, lipid profile, follicular stimulating hormon (FSH), Luteinizing hormone (LH), total testosterone, prolactin, estradiol, 25(OH)D level were analysed. Presence of uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled lipid metabolism disorders, neurological diseases, heamatological diseases, urinary tract infection, malignencies, chronic kidney failure, metabolic syndrome, psychiatric diseases and/or medical treatment, smoking, history of pelvic surgery, cardiac surgery and pelvic radiotherapy were accepted as exclusion criterias from the study. After IIEF-5 score adjust as 21 point, ROC analyse was used to calculate the cut-off value of 25(OH)D and level of 27.32 ng/mL was calculated as cut-off value. Patients were divided into two group according to 27.32 ng/mL level as a cut off value. Serum 25(OH)D level was lower than 27.32 ng/mL in group 1 (severe and moderate symptomatic group) and higher than 27.32 ng/mL in group 2 (mild symptomatic group).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY | – | Other: 25-Hydroxy vitamin DPatient with serum 25-Hydroxy vitamin D level <27.32 |
| CONTROL | – | Other: 25-Hydroxy vitamin DPatient with serum 25-Hydroxy vitamin D level >27.32 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- patients with erectile dysfunction aged between 18 and 80 years
Key inclusion criteria (1 listed)
- presence of erectile dysfunction
Key exclusion criteria (12 listed)
- Presence of uncontrolled diabetes mellitus,
- Presence of uncontrolled hypertension,
- Presence of uncontrolled lipid metabolism disorders,
- Presence of neurological diseases,
- Presence of heamatological diseases,
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 |
|---|---|---|
| 25-Hydroxy vitamin D27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency | Other | CONTROL, STUDY |
Primary outcome
Laboratory results
Time frame: 1 year
Serum 25 Hydroxy vitamin D levels (ng/mL), group 1 include patients with serum 25 hydroxy vitamin D levels higher than 27.32 ng/ml and Group 2 include patients with serum 25 hydroxy vitamin D levels lower than 27.32 ng/mL
Clinical results
Time frame: 1 year
IIEF-5 quesstionaire score (0-15 point is severe erectile dysfunction, 16-21 point is moderate erectile dysfunction and >21 point is mild erectile dysfunction)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Mustafa Ozan Horsanalı, Dr. principal investigator
Cigli Regional Training Hospital, Urology Department
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 Erectile Dysfunction, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 8 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Laboratory results (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.