Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT00748228
Status:
TERMINATED
Last Update Posted:
2015-06-15
First Post:
2008-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dopamine in Orthostatic Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054972', 'term': 'Postural Orthostatic Tachycardia Syndrome'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012982', 'term': 'Sodium, Dietary'}], 'ancestors': [{'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'This study is being replaced by another protocol.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2008-09-05', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma dopamine-beta-hydroxylase', 'timeFrame': 'at enrollment and after tests'}, {'measure': 'plasma dopamine', 'timeFrame': 'after tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postural Tachycardia Syndrome']}, 'descriptionModule': {'briefSummary': 'One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upright plasma norepinephrine \\> 600 pg/ml, or\n* An increase in heart rate of \\> 30 beats per minute upon standing, and\n* Withdrawal of all medications for at least 3 days, and\n* No associated medical illness, and\n* Age 18 - 60 years old.\n\nExclusion Criteria:\n\n* Older than 60 years of age\n* Routinely taking medications affecting the autonomic nervous system\n* Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS\n* Anemia (Hct \\< 30)\n* Women of childbearing age who are pregnant or nursing\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00748228', 'briefTitle': 'Dopamine in Orthostatic Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Dopamine in Orthostatic Tolerance', 'orgStudyIdInfo': {'id': '040769'}, 'secondaryIdInfos': [{'id': 'HL071784'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': '10 mEq/day dietary sodium', 'interventionNames': ['Dietary Supplement: dietary sodium']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': '150 mEq/day dietary sodium', 'interventionNames': ['Dietary Supplement: dietary sodium']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': '300 mEq/day dietary sodium', 'interventionNames': ['Dietary Supplement: dietary sodium']}], 'interventions': [{'name': 'dietary sodium', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 mEq/day', 'armGroupLabels': ['A']}, {'name': 'dietary sodium', 'type': 'DIETARY_SUPPLEMENT', 'description': '300 mEq/day', 'armGroupLabels': ['C']}, {'name': 'dietary sodium', 'type': 'DIETARY_SUPPLEMENT', 'description': '150 mEq/day dietary sodium', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Emily M Garland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Emily M. Garland', 'investigatorAffiliation': 'Vanderbilt University'}}}}