Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-13 @ 2:34 PM
Study NCT ID:
NCT04116060
Status:
UNKNOWN
Last Update Posted:
2021-01-25
First Post:
2019-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Nitrate and Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded and randomised'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment to intervention vs. control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of erectile function according to the international index of erectile function (IIEF5) score', 'timeFrame': '4 Weeks', 'description': 'Erectile dysfunction improvement as measured by IIEF5 score (range 5-25)'}], 'secondaryOutcomes': [{'measure': 'Change in oral microbiome', 'timeFrame': '4 Weeks', 'description': 'Change in oral microbiome after dietary nitrate ingestion'}, {'measure': 'Change in cardiac diastolic function,', 'timeFrame': '4 weeks', 'description': "Change in cardiac diastolic function as determined by echocardiography via measurement of E/A and E/e' aggregated to display diastolic function"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': '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.\n\nWhether dietary nitrate improves erectile dysfunction is not known and will be investigated in the present study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years\n\nExclusion Criteria:\n\n* Spinal cord disease\n* Insulin dependent Diabetes mellitus\n* Prostate cancer after operation, radiotherapy and hormone therapy\n* Treatment with NO-Donators or sGC-Activators\n* Chronic kidney disease (Stage IV-V)\n* Advanced liver dysfunction'}, 'identificationModule': {'nctId': 'NCT04116060', 'briefTitle': 'Dietary Nitrate and Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Impact of Dietary Nitrate on Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'Nitrate E.D.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrate', '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', 'interventionNames': ['Dietary Supplement: Dietary Nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', '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', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'Dietary Nitrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)', 'armGroupLabels': ['Nitrate']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45122', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Fadi Al-Rashid, Dr.med.', 'role': 'CONTACT', 'email': 'fadi.al-rashid@uk-essen.de', 'phone': '00492017230'}, {'name': 'Christos Rammos, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Christos Rammos, MD', 'role': 'CONTACT', 'email': 'Christos.Rammos@uk-essen.de', 'phone': '020172384808'}], 'overallOfficials': [{'name': 'Tienush Rassaf, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Essen'}, {'name': 'Christos Rammos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal Investigator', 'investigatorFullName': 'Fadi Al-Rashid', 'investigatorAffiliation': 'University Hospital, Essen'}}}}