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Dietary Nitrate and Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT04116060
Recruitment Status : Unknown
Verified January 2021 by Fadi Al-Rashid, University Hospital, Essen.
Recruitment status was:  Recruiting
First Posted : October 4, 2019
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Fadi Al-Rashid, University Hospital, Essen

Study Description
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Brief Summary:

An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet. Nitrate improves vascular functions in old adults and improves ischemia reperfusion injury in experimental models.

Whether dietary nitrate improves erectile dysfunction is not known and will be investigated in the present study.


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Dietary Supplement: Dietary Nitrate Dietary Supplement: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment to intervention vs. control
Masking: Double (Participant, Investigator)
Masking Description: Double blinded and randomised
Primary Purpose: Basic Science
Official Title: Impact of Dietary Nitrate on Erectile Dysfunction
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nitrate
Dietary nitrate dissolved in water (0,12 mmol sodium-nitrate/kgBW/day) Dietary Supplement: Dietary nitrate 200 ml tab water with 0,12 mmol/kgBW sodium-nitrate
 Dietary Supplement: Dietary Nitrate
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
Placebo Comparator: Control
Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day) Dietary Supplement: Dietary sodium-chloride 200 ml tab water with 0,12 mmol/kgBW sodium-chloride
 Dietary Supplement: Control
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)


Outcome Measures
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Primary Outcome Measures :
  1. The changes of erectile function according to the international index of erectile function (IIEF5) score [ Time Frame: 4 Weeks ]
    Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)


Secondary Outcome Measures :
  1. Change in oral microbiome [ Time Frame: 4 Weeks ]
    Change in oral microbiome after dietary nitrate ingestion

  2. Change in cardiac diastolic function, [ Time Frame: 4 weeks ]
    Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years

Exclusion Criteria:

  • Spinal cord disease
  • Insulin dependent Diabetes mellitus
  • Prostate cancer after operation, radiotherapy and hormone therapy
  • Treatment with NO-Donators or sGC-Activators
  • Chronic kidney disease (Stage IV-V)
  • Advanced liver dysfunction
Contacts and Locations
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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): NCT04116060


Contacts
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Contact: Christos Rammos, MD 020172384808 Christos.Rammos@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, NRW, Germany, 45122
Contact: Fadi Al-Rashid, Dr.med.    00492017230    fadi.al-rashid@uk-essen.de   
Principal Investigator: Christos Rammos, MD, PHD         
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Study Director: Tienush Rassaf, Prof University Hospital, Essen
Principal Investigator: Christos Rammos, MD University Hospital, Essen
More Information
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Responsible Party: Fadi Al-Rashid, MD, Principal Investigator, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04116060    
Other Study ID Numbers: Nitrate E.D.
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Sexual Dysfunction, Physiological
Male Urogenital Diseases
Sexual Dysfunctions, Psychological
Mental Disorders