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

Primary Purpose

Immune Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control: Placebo
bovine lactoferrin supplement
Sponsored by
Mead Johnson Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Immune Health

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control: Placebo

Investigational: 600 mg bovine lactoferrin supplement

Arm Description

Control: Placebo

Investigational: 600 mg bovine lactoferrin supplement

Outcomes

Primary Outcome Measures

Number of Respiratory Tract Infections

Secondary Outcome Measures

Severity of Respiratory Tract Infection
Mild, Moderate, or Severe rating
Duration of Respiratory Tract Infection
Number of Respiratory Tract Infections
Treatment of Respiratory Tract Infections
Complications from Respiratory Tract Infections
Microorganism causing Respiratory Tract Infection
Level of protective antibody against influenza virus
Inflammatory cytokine
Protection against apoptosis and oxidative stress
Salivary level of lactoferrin
Salivary level of thiocyanate
Salivary level of hypohalous acid
Complete Blood Count
Comprehensive Metabolic Panel
Body Weight
Short Form (12) Health Survey Version 2 (SF-12v2®)
Use of medical treatments
Medically confirmed Adverse Events
COVID Vaccine specific inflammatory panel
IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines
Influenza Hemagglutination-inhibition Antibody Titer
Cytokine Panel

Full Information

First Posted
January 8, 2021
Last Updated
October 17, 2023
Sponsor
Mead Johnson Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT04713735
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mead Johnson Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control: Placebo
Arm Type
Placebo Comparator
Arm Description
Control: Placebo
Arm Title
Investigational: 600 mg bovine lactoferrin supplement
Arm Type
Experimental
Arm Description
Investigational: 600 mg bovine lactoferrin supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Control: Placebo
Intervention Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
bovine lactoferrin supplement
Intervention Description
600 mg
Primary Outcome Measure Information:
Title
Number of Respiratory Tract Infections
Time Frame
365 days
Secondary Outcome Measure Information:
Title
Severity of Respiratory Tract Infection
Description
Mild, Moderate, or Severe rating
Time Frame
365 days
Title
Duration of Respiratory Tract Infection
Time Frame
365 days
Title
Number of Respiratory Tract Infections
Time Frame
180 days
Title
Treatment of Respiratory Tract Infections
Time Frame
365 days
Title
Complications from Respiratory Tract Infections
Time Frame
365 days
Title
Microorganism causing Respiratory Tract Infection
Time Frame
365 days
Title
Level of protective antibody against influenza virus
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Inflammatory cytokine
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Protection against apoptosis and oxidative stress
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Salivary level of lactoferrin
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Salivary level of thiocyanate
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Salivary level of hypohalous acid
Time Frame
Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Complete Blood Count
Time Frame
Baseline, Day 45, Day 90, Day 180, and Day 365
Title
Comprehensive Metabolic Panel
Time Frame
Baseline, Day 45, Day 90, Day 180, and Day 365
Title
Body Weight
Time Frame
Baseline, Day 45, Day 90, Day 180, and Day 365
Title
Short Form (12) Health Survey Version 2 (SF-12v2®)
Time Frame
Baseline, Day 45, Day 90, Day 180, and Day 365
Title
Use of medical treatments
Time Frame
365 days
Title
Medically confirmed Adverse Events
Time Frame
365 days
Title
COVID Vaccine specific inflammatory panel
Description
IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines
Time Frame
Day 45, Day 90, Day 180, Day 270, and Day 365
Title
Influenza Hemagglutination-inhibition Antibody Titer
Time Frame
Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Title
Cytokine Panel
Time Frame
Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Wu, MD
Organizational Affiliation
Mead Johnson/RB
Official's Role
Study Director
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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