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The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01626300
First received: June 20, 2012
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition
To Evaluate the Effects of Milk Components (Whey and/or Inulin)
on the Response to Pneumococcal Vaccines in the Elderly.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens: A Randomized Placebo-controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by University of California, Davis:

Enrollment: 45
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy subjects > 60 years of age.

Criteria

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01626300     History of Changes
Other Study ID Numbers: 200513884-2
Study First Received: June 20, 2012
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013