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Trial record 19 of 19 for:    "Hypogonadism" | "Calcium, Dietary"

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

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ClinicalTrials.gov Identifier: NCT03867929
Recruitment Status : Active, not recruiting
First Posted : March 8, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital

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).

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Study Type : Observational [Patient Registry]
Estimated 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867929


Locations
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Turkey
Cigli Regional Training Hospital
İzmir, Turkey
Sponsors and Collaborators
Recep Tayyip Erdogan University Training and Research Hospital
Investigators
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Principal Investigator: Mustafa Ozan Horsanalı, Dr. Cigli Regional Training Hospital, Urology Department

Additional Information:

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Responsible Party: Mustafa Ozan HORSANALI, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03867929     History of Changes
Other Study ID Numbers: 2
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Calcium-Regulating Hormones and Agents
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents