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

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03867929

Collaborator

(none)

130

Enrollment

Location

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Other: 25-Hydroxy vitamin D

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 1, 2017

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
STUDY Patient with serum 25-Hydroxy vitamin D level <27.32	Other: 25-Hydroxy vitamin D 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	Other: 25-Hydroxy vitamin D 27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency

Arm

Intervention/Treatment

STUDY

Patient with serum 25-Hydroxy vitamin D level <27.32

Other: 25-Hydroxy vitamin D

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

Other: 25-Hydroxy vitamin D

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

Outcome Measures

Primary Outcome Measures

Laboratory results [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 [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)