Clinical trial NCT03867929: Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
Official title: Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Vitamin-D
Hypogonadism
Endothelial Dysfunction
Nitric Oxide
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with erectile dysfunction aged between 18 and 80 years

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Laboratory results
timeFrame: 1 year
measure: Clinical results
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Cigli Regional Training Hospital
Study officials:
affiliation: Cigli Regional Training Hospital, Urology Department
name: Mustafa Ozan Horsanalı, Dr.
role: PRINCIPAL_INVESTIGATOR
References: