Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-31 @ 8:19 AM
Study NCT ID:
NCT00240461
Status:
COMPLETED
Last Update Posted:
2011-07-07
First Post:
2005-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'C511203', 'term': 'COLD-fX'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 780}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.', 'timeFrame': 'During the study time frame of 6 months'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effects of the treatment on the incidence and frequency of all respiratory infections meeting the Jackson criteria and to determine the efficacy of COLD-fX supplementation on the severity and duration of symptoms.', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['respiratory', 'infection', 'influenza'], 'conditions': ['Respiratory Tract Infection']}, 'descriptionModule': {'briefSummary': 'Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.', 'detailedDescription': 'Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years of age and older\n* current season influenza immunization\n* available for follow-up visits\n* willing and able to sign written informed consent\n\nExclusion Criteria:\n\n* HIV infection\n* malignancy (under active observation or treatment)\n* unstable cardiovascular diseases\n* renal abnormalities (serum creatine \\>200umol/l)\n* pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone \\>10mg/day, other chronic respiratory illness)\n* acute or active chronic liver disease\n* neurologic or psychiatric disease (progressive or currently under treatment\n* active tuberculosis\n* multiple sclerosis\n* bleeding disorders\n* planned surgery over the course of the trial\n* on immunosuppressive therapy\n* taking oral steroids at dose = to prednisone 10 mg/day or more\n* taking phenelzine, pentobarbital, haloperidol, warfarin, heparin\n* use of natural health products(except the study product and vitamins and minerals with a dose \\<600 mg/day of vitamin E and containing no vitamin K) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets)\n* current alcohol/drug abuse\n* major surgery in the past 6 months\n* allergies to ginseng'}, 'identificationModule': {'nctId': 'NCT00240461', 'briefTitle': 'Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors', 'organization': {'class': 'OTHER', 'fullName': 'Capital Health, Canada'}, 'officialTitle': 'Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'CVT-E002-2005-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '200 mg COLD-fX Natural health products 2 times daily for six months', 'interventionNames': ['Dietary Supplement: COLD-fX natural health product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months', 'interventionNames': ['Dietary Supplement: COLD-fX']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Inactive crystalline substance. This is the placebo arm in which subject receive 200 mg of the placebo 2 times daily for 6 months. Placebo is an inactive crystalline substance.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'COLD-fX natural health product', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Natural health product', 'dietary supplement'], 'description': '200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months', 'armGroupLabels': ['1']}, {'name': 'COLD-fX', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['naural health products', 'dietary supplements'], 'description': '400 mg COLD-fX natural health product 2 times daily for 6 months', 'armGroupLabels': ['Arm 2']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['none available'], 'description': 'crystalline substance 200 mg twice daily for 6 months', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5M 3Z7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'UBC Gerontology and Diabetes Research', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Dr. Albert Osterhaus', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Gerry Predy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Health, Canada'}, {'name': 'Shelly McNeil MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}, {'name': 'Jan McElhaney', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UBC Gerontology and Diabetes Research'}, {'name': 'Andrew Simor MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Albert Osterhaus Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Health, Canada', 'class': 'OTHER'}, 'collaborators': [{'name': 'Afexa Life Sciences Inc', 'class': 'INDUSTRY'}, {'name': 'IWK Health Centre', 'class': 'OTHER'}, {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'University of BC Gerontology & Diabetes Research', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Gerry Predy', 'oldOrganization': 'Capital Health'}}}}