Erectile DysfunctionNCT04116060
Dietary Nitrate and Erectile Dysfunction
A study testing Dietary Nitrate in people with Erectile Dysfunction, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Dietary Nitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 17 Feb 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen, North Rhine-Westphalia, 45122
Fadi Al-Rashid, Dr.med., 00492017230, fadi.al-rashid@uk-essen.de
Christos Rammos, MD, PHD
About this study
Official title: Impact of Dietary Nitrate on Erectile Dysfunction
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.
- Conditions
- Erectile Dysfunction
- Being tested
- Dietary Nitrate, Control
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary NitrateDietary supplement
Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
ControlDietary supplement
Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)
| Study group | Role | What they receive |
|---|---|---|
| Nitrate | Experimental | 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 Receives: Dietary Supplement: Dietary Nitrate |
| Control | Placebo comparator | 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 Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 Weeks
Secondary outcomes (2)
Change in oral microbiome
Change in oral microbiome after dietary nitrate ingestion
Measured: 4 Weeks
Change in cardiac diastolic function,
Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start17 Feb 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment to intervention vs. control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Al-Rashid, University Hospital, Essen
- Investigators
- Tienush Rassaf, Prof, Study director, University Hospital, EssenChristos Rammos, MD, Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116060
- Sponsor's protocol ID
- Nitrate E.D.
- Status last verified
- Jan 2021
- First submitted
- 3 Oct 2019
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Nitrate on Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04116060
- Acronym / sponsor ID
- Nitrate E.D.
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment to intervention vs. control
| Arm | Type | Receives |
|---|---|---|
| Nitrate | Experimental | Dietary Supplement: Dietary NitrateDietary 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 comparator | Dietary Supplement: ControlDietary 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary NitrateOral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate) | Dietary supplement | Nitrate |
| ControlPlacebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day) | Dietary supplement | Control |
Primary outcome
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)
2 secondary outcomes
Change in oral microbiome
Time frame: 4 Weeks
Change in cardiac diastolic function,
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tienush Rassaf, Prof study director
University Hospital, Essen
Christos Rammos, MD principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Nitrate in people with Erectile Dysfunction, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos Rammos, MD (020172384808, Christos.Rammos@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of erectile function according to the international index of erectile function (IIEF5) score (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.