Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02371993
Status:
COMPLETED
Last Update Posted:
2015-10-29
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asthma in the Elderly: A Study of Choline Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002794', 'term': 'Choline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-28', 'studyFirstSubmitDate': '2015-02-10', 'studyFirstSubmitQcDate': '2015-02-24', 'lastUpdatePostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test', 'timeFrame': 'six weeks'}, {'measure': 'Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)', 'timeFrame': 'six weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of choline supplementation on peripheral blood eosinophils', 'timeFrame': 'six weeks'}, {'measure': 'Effect of choline supplementation on serum IgE', 'timeFrame': 'six weeks'}, {'measure': 'Effect of choline supplementation on serum homocysteine levels', 'timeFrame': 'six weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Asthma in the Elderly']}, 'referencesModule': {'references': [{'pmid': '26973701', 'type': 'DERIVED', 'citation': 'Columbo M, Rohr AS. Asthma in the elderly: the effect of choline supplementation. Allergy Asthma Clin Immunol. 2016 Mar 11;12:15. doi: 10.1186/s13223-016-0121-5. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma\n\nExclusion Criteria:\n\n* No history of smoking more than 10 pack/years,\n* no gastrointestinal cancers,\n* no liver or kidney disease,\n* no bipolar disorder.'}, 'identificationModule': {'nctId': 'NCT02371993', 'briefTitle': 'Asthma in the Elderly: A Study of Choline Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.'}, 'officialTitle': 'Asthma in the Elderly: A Study of Choline Supplementation', 'orgStudyIdInfo': {'id': 'F/N-R15-3427B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choline 650 mg twice daily', 'description': 'See above', 'interventionNames': ['Dietary Supplement: Choline', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'See above', 'interventionNames': ['Dietary Supplement: Choline', 'Other: Placebo']}], 'interventions': [{'name': 'Choline', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Choline 650 mg twice daily', 'Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Choline 650 mg twice daily', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}], 'overallOfficials': [{'name': 'Michele Columbo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michele Columbo, M.D.', 'investigatorAffiliation': 'Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.'}}}}