Dietary Nitrate and Erectile Dysfunction

NCT ID: NCT04116060

Last Updated: 2021-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment to intervention vs. control
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double blinded and randomised

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Dietary Nitrate

Intervention Type DIETARY_SUPPLEMENT

Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Nitrate

Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)

Intervention Type DIETARY_SUPPLEMENT

Control

Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fadi Al-Rashid

MD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tienush Rassaf, Prof

Role: STUDY_DIRECTOR

University Hospital, Essen

Christos Rammos, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christos Rammos, MD

Role: CONTACT

020172384808

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fadi Al-Rashid, Dr.med.

Role: primary

00492017230

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Nitrate E.D.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

L-Arginine and Erectile Dysfunction
NCT00777075 COMPLETED PHASE4
A Study in Erectile Dysfunction
NCT01130532 COMPLETED PHASE4
Diabetes & Vardenafil
NCT02219646 COMPLETED PHASE2