Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT00249704
Status:
TERMINATED
Last Update Posted:
2009-01-08
First Post:
2005-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-07', 'studyFirstSubmitDate': '2005-11-03', 'studyFirstSubmitQcDate': '2005-11-04', 'lastUpdatePostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.', 'timeFrame': 'Throughout trial'}], 'secondaryOutcomes': [{'measure': 'Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.', 'timeFrame': 'throughout trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elderly, Frail']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001116&StudyName=Randomized%20study%20of%20exercise%20and%20Vitamin%20D%20in%20Frail%20Elderly%20subjects.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.', 'detailedDescription': 'The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly subjects with moderate frailty residing in assisted living facilities.\n\nExclusion Criteria:\n\n* Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.'}, 'identificationModule': {'nctId': 'NCT00249704', 'briefTitle': 'Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects', 'orgStudyIdInfo': {'id': 'A9001116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C', 'interventionNames': ['Procedure: Vitamin D Placebo + Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: Vitamin D + Sham Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Vitamin D + Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'interventionNames': ['Procedure: Vitamin D Placebo + Sham Exercise']}], 'interventions': [{'name': 'Vitamin D + Sham Exercise', 'type': 'DRUG', 'description': '1000 IU per day of Vitamin D + Sham (equivalent to placebo) Exercise', 'armGroupLabels': ['B']}, {'name': 'Vitamin D Placebo + Exercise', 'type': 'PROCEDURE', 'description': 'Vitamin D placebo + Exercise', 'armGroupLabels': ['C']}, {'name': 'Vitamin D Placebo + Sham Exercise', 'type': 'PROCEDURE', 'description': 'Vitamin D placebo + Sham (equivalent to placebo) Exercise', 'armGroupLabels': ['D']}, {'name': 'Vitamin D + Exercise', 'type': 'DRUG', 'description': '1000 IU per day of Vitamin D + Exercise', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030-5215', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '02131-1011', 'city': 'Roslindale', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.29121, 'lon': -71.1245}}, {'zip': '10040-3403', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}