Status:
COMPLETED
Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Immune Health
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on respiratory tract infections (RTIs) in an elderly population in the United States.
Eligibility Criteria
Inclusion
- Aged ≥ 55 years of age at time of consent
- Able to eat and drink, with assistance if required
- Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study
- Signed consent obtained from subject or legally authorized representative
- Signed authorization obtained to use and/or disclose Protected Health Information
Exclusion
- Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition
- Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation
- Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject
- Known allergy or intolerance to study products
- On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months
- Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration
- Have experienced Respiratory Tract Infection within 1 week prior to randomization
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04713735
Start Date
February 8 2021
End Date
April 28 2023
Last Update
October 18 2023
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073