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Completed

NCT Number: NCT03867929

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Cigli Regional Training Hospital

Izmir, Turkey (Türkiye)

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25-Hydroxy vitamin D

Other

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

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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