Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections
Not Applicable
Completed
- Conditions
- Immune Health
- Interventions
- Dietary Supplement: bovine lactoferrin supplement
- Registration Number
- NCT04713735
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational: 600 mg bovine lactoferrin supplement bovine lactoferrin supplement Investigational: 600 mg bovine lactoferrin supplement
- Primary Outcome Measures
Name Time Method Number of Respiratory Tract Infections 365 days
- Secondary Outcome Measures
Name Time Method Comprehensive Metabolic Panel Baseline, Day 45, Day 90, Day 180, and Day 365 Short Form (12) Health Survey Version 2 (SF-12v2®) Baseline, Day 45, Day 90, Day 180, and Day 365 COVID Vaccine specific inflammatory panel Day 45, Day 90, Day 180, Day 270, and Day 365 IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines
Complications from Respiratory Tract Infections 365 days Duration of Respiratory Tract Infection 365 days Number of Respiratory Tract Infections 180 days Salivary level of thiocyanate Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Microorganism causing Respiratory Tract Infection 365 days Salivary level of lactoferrin Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Complete Blood Count Baseline, Day 45, Day 90, Day 180, and Day 365 Influenza Hemagglutination-inhibition Antibody Titer Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 Severity of Respiratory Tract Infection 365 days Mild, Moderate, or Severe rating
Inflammatory cytokine Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Body Weight Baseline, Day 45, Day 90, Day 180, and Day 365 Treatment of Respiratory Tract Infections 365 days Level of protective antibody against influenza virus Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Salivary level of hypohalous acid Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Use of medical treatments 365 days Cytokine Panel Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 Protection against apoptosis and oxidative stress Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 Medically confirmed Adverse Events 365 days
Trial Locations
- Locations (1)
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States