Dietary Nitrate and Erectile Dysfunction
Impact of Dietary Nitrate on Erectile Dysfunction
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 4, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJanuary 25, 2021
January 1, 2021
1.3 years
October 3, 2019
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The changes of erectile function according to the international index of erectile function (IIEF5) score
Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)
4 Weeks
Secondary Outcomes (2)
Change in oral microbiome
4 Weeks
Change in cardiac diastolic function,
4 weeks
Study Arms (2)
Nitrate
EXPERIMENTALDietary 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
Control
PLACEBO COMPARATORDietary 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
Interventions
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)
Eligibility Criteria
You may qualify if:
- Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Essen
Essen, North Rhine-Westphalia, 45122, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tienush Rassaf, Prof
University Hospital, Essen
- PRINCIPAL INVESTIGATOR
Christos Rammos, MD
University Hospital, Essen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blinded and randomised
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Principal Investigator
Study Record Dates
First Submitted
October 3, 2019
First Posted
October 4, 2019
Study Start
February 17, 2020
Primary Completion
June 1, 2021
Study Completion
August 1, 2021
Last Updated
January 25, 2021
Record last verified: 2021-01