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

• ClinicalTrials.gov Identifier: NCT03867929
• Recruitment Status: Completed
• First Posted: March 8, 2019
• Last Update Posted: October 8, 2020
• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Information provided by (Responsible Party): Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital

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
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
• Target Follow-Up Duration: 15 Months
• Official Title: Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: September 1, 2020

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Laboratory results [ Time Frame: 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
2. Clinical results [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: erectile dysfunction
• Sampling Method: Probability Sample

Study Population

patients with erectile dysfunction aged between 18 and 80 years

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

Contacts and Locations

Locations

Turkey

Cigli Regional Training Hospital

İzmir, Turkey

Sponsors and Collaborators

Recep Tayyip Erdogan University Training and Research Hospital

Investigators

• Principal Investigator: Mustafa Ozan Horsanalı, Dr.; Cigli Regional Training Hospital, Urology Department

More Information

Additional Information:

• Responsible Party: Mustafa Ozan HORSANALI, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03867929
• Other Study ID Numbers: 2
• First Posted: March 8, 2019
• Last Update Posted: October 8, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital:

Erectile dysfunction; Vitamin-D; Hypogonadism; Endothelial Dysfunction; Nitric Oxide

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Vitamin D; Hydroxycholecalciferols; Calcifediol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents