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OpenTrials
Completed

NCT Number: NCT04713735

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

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.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control: Placebo

Dietary Supplement

Placebo

bovine lactoferrin supplement

Dietary Supplement

600 mg

Primary outcomes

  1. Number of Respiratory Tract Infections

    Time frame: 365 days

Secondary outcomes

  1. Severity of Respiratory Tract Infection

    Time frame: 365 days

    Mild, Moderate, or Severe rating

  2. Duration of Respiratory Tract Infection

    Time frame: 365 days

  3. Number of Respiratory Tract Infections

    Time frame: 180 days

  4. Treatment of Respiratory Tract Infections

    Time frame: 365 days

  5. Complications from Respiratory Tract Infections

    Time frame: 365 days

  6. Microorganism causing Respiratory Tract Infection

    Time frame: 365 days

  7. Level of protective antibody against influenza virus

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  8. Inflammatory cytokine

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  9. Protection against apoptosis and oxidative stress

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  10. Salivary level of lactoferrin

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  11. Salivary level of thiocyanate

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  12. Salivary level of hypohalous acid

    Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365

  13. Complete Blood Count

    Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365

  14. Comprehensive Metabolic Panel

    Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365

  15. Body Weight

    Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365

  16. Short Form (12) Health Survey Version 2 (SF-12v2®)

    Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365

  17. Use of medical treatments

    Time frame: 365 days

  18. Medically confirmed Adverse Events

    Time frame: 365 days

  19. COVID Vaccine specific inflammatory panel

    Time frame: Day 45, Day 90, Day 180, Day 270, and Day 365

    IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines

  20. Influenza Hemagglutination-inhibition Antibody Titer

    Time frame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28

  21. Cytokine Panel

    Time frame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 19, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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