NCT04713735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
Last Updated

October 18, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

January 8, 2021

Last Update Submit

October 17, 2023

Conditions

Immune Health

Outcome Measures

Primary Outcomes (1)

  • Number of Respiratory Tract Infections

    365 days

Secondary Outcomes (21)

  • Severity of Respiratory Tract Infection

    365 days

  • Duration of Respiratory Tract Infection

    365 days

  • Number of Respiratory Tract Infections

    180 days

  • Treatment of Respiratory Tract Infections

    365 days

  • Complications from Respiratory Tract Infections

    365 days

  • +16 more secondary outcomes

Study Arms (2)

Control: Placebo

PLACEBO COMPARATOR

Control: Placebo

Dietary Supplement: Control: Placebo

Investigational: 600 mg bovine lactoferrin supplement

EXPERIMENTAL

Investigational: 600 mg bovine lactoferrin supplement

Dietary Supplement: bovine lactoferrin supplement

Interventions

Control: PlaceboDIETARY_SUPPLEMENT

Placebo

Control: Placebo
bovine lactoferrin supplementDIETARY_SUPPLEMENT

600 mg

Investigational: 600 mg bovine lactoferrin supplement

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Have experienced Respiratory Tract Infection within 1 week prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Location

Study Officials

  • Steven Wu, MD

    Mead Johnson/RB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 19, 2021

Study Start

February 8, 2021

Primary Completion

February 28, 2022

Study Completion

April 28, 2023

Last Updated

October 18, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)