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CompletedNCT03867929Updated Oct 8, 2020

Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction

An observational study in Erectile Dysfunction, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
130
Ages
18 Years to 80 Years
Sex
Male
01

Study 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 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).

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile dysfunction
  • Vitamin-D
  • Hypogonadism
  • Endothelial Dysfunction
  • Nitric Oxide
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 130 is close to the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Sampling method
Probability sample

Study population

patients with erectile dysfunction aged between 18 and 80 years

Inclusion criteria

  • presence of erectile dysfunction

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
130 participants (actual)
Target follow-up
15 Months
Patient registry
Yes

Groups and cohorts

  • STUDY

    Patient with serum 25-Hydroxy vitamin D level \<27.32

    Other: 25-Hydroxy vitamin D

  • CONTROL

    Patient with serum 25-Hydroxy vitamin D level \>27.32

    Other: 25-Hydroxy vitamin D

Interventions

  • Other25-Hydroxy vitamin D

    27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

  2. 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)

    Time frame: 1 year

07

Study locations

1 site
  • Cigli Regional Training Hospital
    İzmir, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03867929
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Mustafa Ozan HORSANALI (Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Mar 8, 2019
Start date
Jun 1, 2017
Primary completion
Sep 1, 2019
Completion
Sep 1, 2020
Last update
Oct 8, 2020

Study contacts

Mustafa Ozan Horsanalı, Dr.
principal investigator · Cigli Regional Training Hospital, Urology Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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