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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867929
• Other study ID #: 2
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2019
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• 25-Hydroxy vitamin D
27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency

Locations

Country	Name	City	State
Turkey	Cigli Regional Training Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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