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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Cigli Regional Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

patients with erectile dysfunction aged between 18 and 80 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Investigators: Principal Investigator: Mustafa Ozan Horsanalı, Dr., Cigli Regional Training Hospital, Urology Department

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Hypogonadism; Erectile dysfunction; Nitric Oxide; Endothelial Dysfunction; Vitamin-D
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Calcifediol; Hydroxycholecalciferols
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No