Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections

Immune Health Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713735
• Other study ID #: 3393-1
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: March 2023
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 28, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Health
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Control: Placebo
Placebo
• bovine lactoferrin supplement
600 mg

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Respiratory Tract Infections		365 days
Secondary	Severity of Respiratory Tract Infection	Mild, Moderate, or Severe rating	365 days
Secondary	Duration of Respiratory Tract Infection		365 days
Secondary	Number of Respiratory Tract Infections		180 days
Secondary	Treatment of Respiratory Tract Infections		365 days
Secondary	Complications from Respiratory Tract Infections		365 days
Secondary	Microorganism causing Respiratory Tract Infection		365 days
Secondary	Level of protective antibody against influenza virus		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Inflammatory cytokine		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Protection against apoptosis and oxidative stress		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Salivary level of lactoferrin		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Salivary level of thiocyanate		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Salivary level of hypohalous acid		Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Complete Blood Count		Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary	Comprehensive Metabolic Panel		Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary	Body Weight		Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary	Short Form (12) Health Survey Version 2 (SF-12v2®)		Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary	Use of medical treatments		365 days
Secondary	Medically confirmed Adverse Events		365 days
Secondary	COVID Vaccine specific inflammatory panel	IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines	Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary	Influenza Hemagglutination-inhibition Antibody Titer		Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Secondary	Cytokine Panel		Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28