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

NCT ID: NCT03867929

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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STUDY

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

25-Hydroxy vitamin D

Intervention Type OTHER

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

CONTROL

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

25-Hydroxy vitamin D

Intervention Type OTHER

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

Interventions

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25-Hydroxy vitamin D

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* presence of erectile dysfunction

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mustafa Ozan HORSANALI

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Ozan Horsanalı, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cigli Regional Training Hospital, Urology Department

Locations

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Cigli Regional Training Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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