- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626300
The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens
June 19, 2017 updated by: University of California, Davis
The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens: A Randomized Placebo-controlled Clinical Trial
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
45
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy subjects > 60 years of age.
Description
Inclusion Criteria:
- Age and a willingness to participate
Exclusion Criteria:
• Smoking history within 10 years
- Underlying neoplasia or immunological disease
- Use of oral cortisone or other immunosuppressive agents
- Current consumption of milk and milk products greater than 1 unit of milk, 1 yogurt, or 1 serving of fresh cheese a day.
- Food faddists or those taking a non-traditional diet
- Current consumption of dietary supplements
- People with a known history of milk allergy
- People with chronic renal failure
- People with chronic inflammatory diseases taking daily doses of NSAIDs for longer than 4 weeks at the time of enrollment.
- Previous administration of the pneumomax vaccine
- Reduced physical activity (i.e. NYHA classes III-IV)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
June 20, 2012
First Submitted That Met QC Criteria
June 21, 2012
First Posted (Estimate)
June 22, 2012
Study Record Updates
Last Update Posted (Actual)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200513884
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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