NCT03867929

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

February 22, 2019

Last Update Submit

October 6, 2020

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionVitamin-DHypogonadismEndothelial DysfunctionNitric Oxide

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    1 year

Study Arms (2)

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

25-Hydroxy vitamin DOTHER

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

CONTROLSTUDY

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailserectile dysfunction
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with erectile dysfunction aged between 18 and 80 years

You may qualify if:

  • presence of erectile dysfunction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigli Regional Training Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile DysfunctionHypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersGonadal DisordersEndocrine System Diseases

Study Officials

  • Mustafa Ozan Horsanalı, Dr.

    Cigli Regional Training Hospital, Urology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 8, 2019

Study Start

June 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)