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

NCT ID: NCT04713735

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-08

Study Completion Date

2023-04-28

Brief Summary

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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

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Conditions

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Immune Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control: Placebo

Control: Placebo

Group Type PLACEBO_COMPARATOR

Control: Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Investigational: 600 mg bovine lactoferrin supplement

Investigational: 600 mg bovine lactoferrin supplement

Group Type EXPERIMENTAL

bovine lactoferrin supplement

Intervention Type DIETARY_SUPPLEMENT

600 mg

Interventions

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Control: Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

bovine lactoferrin supplement

600 mg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Wu, MD

Role: STUDY_DIRECTOR

Mead Johnson/RB

Locations

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VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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3393-1

Identifier Type: -

Identifier Source: org_study_id

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