Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-06-06 @ 5:40 PM
Study NCT ID:
NCT01626300
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2012-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['The Effect of Milk Components on the Response to Pneumococcal Vaccines in the Elderly']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the daily use of a certain amount and type of milk component for 2 months provides a significant stimulation to the immune system and specifically increases the chances of being protected against pneumonia after the vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects \\> 60 years of age.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age and a willingness to participate\n\nExclusion Criteria:\n\n* • Smoking history within 10 years\n\n * Underlying neoplasia or immunological disease\n * Use of oral cortisone or other immunosuppressive agents\n * Current consumption of milk and milk products greater than 1 unit of milk, 1 yogurt, or 1 serving of fresh cheese a day.\n * Food faddists or those taking a non-traditional diet\n * Current consumption of dietary supplements\n * People with a known history of milk allergy\n * People with chronic renal failure\n * People with chronic inflammatory diseases taking daily doses of NSAIDs for longer than 4 weeks at the time of enrollment.\n * Previous administration of the pneumomax vaccine\n * Reduced physical activity (i.e. NYHA classes III-IV)'}, 'identificationModule': {'nctId': 'NCT01626300', 'briefTitle': 'The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens: A Randomized Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': '200513884'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}