Clinical trial NCT04713735: Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Health
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Respiratory Tract Infections
timeFrame: 365 days
Secondary outcomes:
measure: Severity of Respiratory Tract Infection
timeFrame: 365 days
measure: Duration of Respiratory Tract Infection
timeFrame: 365 days
measure: Number of Respiratory Tract Infections
timeFrame: 180 days
measure: Treatment of Respiratory Tract Infections
timeFrame: 365 days
measure: Complications from Respiratory Tract Infections
timeFrame: 365 days
measure: Microorganism causing Respiratory Tract Infection
timeFrame: 365 days
measure: Level of protective antibody against influenza virus
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Inflammatory cytokine
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Protection against apoptosis and oxidative stress
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Salivary level of lactoferrin
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Salivary level of thiocyanate
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Salivary level of hypohalous acid
timeFrame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Complete Blood Count
timeFrame: Baseline, Day 45, Day 90, Day 180, and Day 365
measure: Comprehensive Metabolic Panel
timeFrame: Baseline, Day 45, Day 90, Day 180, and Day 365
measure: Body Weight
timeFrame: Baseline, Day 45, Day 90, Day 180, and Day 365
measure: Short Form (12) Health Survey Version 2 (SF-12v2®)
timeFrame: Baseline, Day 45, Day 90, Day 180, and Day 365
measure: Use of medical treatments
timeFrame: 365 days
measure: Medically confirmed Adverse Events
timeFrame: 365 days
measure: COVID Vaccine specific inflammatory panel
timeFrame: Day 45, Day 90, Day 180, Day 270, and Day 365
measure: Influenza Hemagglutination-inhibition Antibody Titer
timeFrame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
measure: Cytokine Panel
timeFrame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: Mead Johnson/RB
name: Steven Wu, MD
role: STUDY_DIRECTOR
References: