Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-01 @ 11:06 AM
Study NCT ID:
NCT00728104
Status:
WITHDRAWN
Last Update Posted:
2017-02-06
First Post:
2008-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536228', 'term': 'Familial cyclic vomiting syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-03', 'studyFirstSubmitDate': '2008-07-31', 'studyFirstSubmitQcDate': '2008-08-04', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How two vitamin supplements are being used to treat cyclic vomiting syndrome', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'How effective these supplements appear to be compared to standard treatment', 'timeFrame': 'Two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Learn', 'L-Carnitine', 'Co-enzyme Q10', 'Effective', 'These supplements', 'Compared', 'Standard'], 'conditions': ['Cyclic Vomiting Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cvsaonline.org', 'label': 'Cyclic Vomiting Syndrome Association'}]}, 'descriptionModule': {'briefSummary': 'This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents. We want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cyclic Vomiting Syndrome (CVS) is a condition where children and adults have repeated attacks of severe vomiting, nausea, abdominal pain, headaches, and tiredness. These episodes can last from several hours to several days.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 3 discrete episodes of vomiting\n* normal health between episodes\n* stereotypical clinical pattern\n* no abnormal test results to account for vomiting (see exclusion criteria)\n\nExclusion Criteria:\n\n* abnormal UGI with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive\n* Significantly abnormal endoscopic biopsies (moderate to severe esophagitis, H. pylori)\n* Abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis\n* Positive screening for endocrine disorder (diabetic ketoacidosis, Addison's)\n* Positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ALA, porphobilinogen)"}, 'identificationModule': {'nctId': 'NCT00728104', 'briefTitle': 'The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study', 'orgStudyIdInfo': {'id': '090'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments'}, {'label': '2', 'description': 'The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10'}, {'label': '3', 'description': 'The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine'}, {'label': '4', 'description': 'The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'B Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wiconsin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics, MD', 'investigatorFullName': 'B Li', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}