Dietary Nitrate and Erectile Dysfunction

University Hospital Essen

Status: Unknown

Conditions: Erectile Dysfunction

Treatments: Dietary Supplement: Dietary Nitrate; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04116060

Nitrate E.D.

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Nitrate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary Nitrate

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control