Dietary Nitrate and Erectile Dysfunction

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

Tracking Information

• First Submitted Date: October 3, 2019
• First Posted Date: October 4, 2019
• Last Update Posted Date: January 25, 2021
• Actual Study Start Date: February 17, 2020
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 20, 2021)

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)

Original Primary Outcome Measures (submitted: October 3, 2019)

The changes of erectile function [ Time Frame: 4 Weeks ]

Erectile dysfunction improvement as measured by IIEF5 score

Current Secondary Outcome Measures (submitted: January 20, 2021)

• Change in oral microbiome [ Time Frame: 4 Weeks ]
  Change in oral microbiome after dietary nitrate ingestion
• 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

Original Secondary Outcome Measures (submitted: October 3, 2019)

• Change in oral microbiome [ Time Frame: 4 Weeks ]
  Change in oral microbiome after dietary nitrate ingestion
• Change in cardiac diastolic function, [ Time Frame: 4 weeks ]
  Change in cardiac diastolic function as determined by echocardiography

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dietary Nitrate and Erectile Dysfunction
• Official Title: Impact of Dietary Nitrate on Erectile Dysfunction

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Erectile Dysfunction

Intervention

• Dietary Supplement: Dietary Nitrate
  Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
• Dietary Supplement: Control
  Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)

Study Arms

• 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
  Intervention: Dietary Supplement: Dietary 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
  Intervention: Dietary Supplement: Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 3, 2019): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2021
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04116060
• Other Study ID Numbers: Nitrate E.D.
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Fadi Al-Rashid, University Hospital, Essen
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Essen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Tienush Rassaf, Prof; University Hospital, Essen
• Principal Investigator: Christos Rammos, MD; University Hospital, Essen

• PRS Account: University Hospital, Essen
• Verification Date: January 2021