Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-11 @ 3:13 PM
Study NCT ID:
NCT02521532
Status:
COMPLETED
Last Update Posted:
2015-10-23
First Post:
2015-01-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2015-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incremental shuttle walk test distance', 'timeFrame': 'Day 1, day 15 and day 29'}], 'secondaryOutcomes': [{'measure': 'Change in plasma nitrate', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Assessed by chemiluminescence'}, {'measure': 'Change in ambulatory blood pressure', 'timeFrame': 'Day 1, day 15 and day 29'}, {'measure': 'Change in quality of life', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Quality of Life will be assessed with the Clinical COPD Questionnaire'}, {'measure': 'Change in forced expiratory volume', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Assessed by spirometry'}, {'measure': 'Change in inflammatory markers', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Assessed by C-reactive protein'}, {'measure': 'Change in forced vital capacity', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Assessed by spirometry'}, {'measure': 'Change in plasma nitrate and nitrite', 'timeFrame': 'Day 1, day 15 and day 29', 'description': 'Assessed by chemiluminescence'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.', 'detailedDescription': 'Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in OSAS has not been reported.\n\nThe investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of life and pulmonary function.\n\nThis study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically stable,\n* Diagnosed with COPD\n* Ambulatory out-patients\n\nExclusion Criteria:\n\n* Long term oxygen therapy\n* Pulmonary hypertension\n* Active cardiovascular disease\n* Active skeletal conditions\n* Taking vasodilators\n* Diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT02521532', 'briefTitle': 'A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Royal College of Surgeons, Ireland'}, 'officialTitle': 'Dietary Nitrate for COPD: a 14d, Randomized, Placebo-controlled, Crossover Trial', 'orgStudyIdInfo': {'id': 'Chronic NO3- in COPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrate rich beetroot juice', 'description': 'Concentrated, beetroot juice is a rich source of dietary nitrate.', 'interventionNames': ['Dietary Supplement: Dietary nitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nitrate depleted placebo beetroot juice', 'description': 'Placebo beetroot juice is identical to active beetroot juice in every way except nitrate content.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Dietary nitrate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beetroot juice'], 'description': '140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.', 'armGroupLabels': ['Nitrate rich beetroot juice']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nitrate depleted beetroot juice'], 'description': '140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.', 'armGroupLabels': ['Nitrate depleted placebo beetroot juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D15', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Respiratory & Sleep Diagnostics Department, Connolly Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Liam Cormican, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Respiratory & Sleep Diagnostics Department, Connolly Hospital, Dublin 15, Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal College of Surgeons, Ireland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College Dublin', 'class': 'OTHER'}, {'name': 'Connolly Hospital Blanchardstown', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}