Immune HealthNCT04713735
Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections
A study testing bovine lactoferrin supplement in people with Immune Health, run by Mead Johnson Nutrition at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immune Health
- What is being tested?
- bovine lactoferrin supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
About this study
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
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.
- Conditions
- Immune Health
- Being tested
- Control: Placebo, bovine lactoferrin supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: PlaceboDietary supplement
Placebo
bovine lactoferrin supplementDietary supplement
600 mg
| Study group | Role | What they receive |
|---|---|---|
| Control: Placebo | Placebo comparator | Control: Placebo Receives: Dietary Supplement: Control: Placebo |
| Investigational: 600 mg bovine lactoferrin supplement | Experimental | Investigational: 600 mg bovine lactoferrin supplement Receives: Dietary Supplement: bovine lactoferrin supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Respiratory Tract Infections
Measured: 365 days
Secondary outcomes (21)
Severity of Respiratory Tract Infection
Mild, Moderate, or Severe rating
Measured: 365 days
Duration of Respiratory Tract Infection
Measured: 365 days
Number of Respiratory Tract Infections
Measured: 180 days
Treatment of Respiratory Tract Infections
Measured: 365 days
Complications from Respiratory Tract Infections
Measured: 365 days
Microorganism causing Respiratory Tract Infection
Measured: 365 days
Level of protective antibody against influenza virus
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Inflammatory cytokine
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Protection against apoptosis and oxidative stress
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of lactoferrin
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of thiocyanate
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of hypohalous acid
Measured: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Complete Blood Count
Measured: Baseline, Day 45, Day 90, Day 180, and Day 365
Comprehensive Metabolic Panel
Measured: Baseline, Day 45, Day 90, Day 180, and Day 365
Body Weight
Measured: Baseline, Day 45, Day 90, Day 180, and Day 365
Short Form (12) Health Survey Version 2 (SF-12v2®)
Measured: Baseline, Day 45, Day 90, Day 180, and Day 365
Use of medical treatments
Measured: 365 days
Medically confirmed Adverse Events
Measured: 365 days
COVID Vaccine specific inflammatory panel
IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines
Measured: Day 45, Day 90, Day 180, Day 270, and Day 365
Influenza Hemagglutination-inhibition Antibody Titer
Measured: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Cytokine Panel
Measured: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start8 Feb 2021
- Primary completion28 Feb 2022
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wu, MD, Study director, Mead Johnson/RB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713735
- Sponsor's protocol ID
- 3393-1
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04713735
- Acronym / sponsor ID
- 3393-1
- Conditions
- Immune Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Placebo | Placebo comparator | Dietary Supplement: Control: PlaceboControl: Placebo |
| Investigational: 600 mg bovine lactoferrin supplement | Experimental | Dietary Supplement: bovine lactoferrin supplementInvestigational: 600 mg bovine lactoferrin supplement |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control: PlaceboPlacebo | Dietary supplement | Control: Placebo |
| bovine lactoferrin supplement600 mg | Dietary supplement | Investigational: 600 mg bovine lactoferrin supplement |
Primary outcome
Number of Respiratory Tract Infections
Time frame: 365 days
21 secondary outcomes
Severity of Respiratory Tract Infection
Time frame: 365 days
Duration of Respiratory Tract Infection
Time frame: 365 days
Number of Respiratory Tract Infections
Time frame: 180 days
Treatment of Respiratory Tract Infections
Time frame: 365 days
Complications from Respiratory Tract Infections
Time frame: 365 days
Microorganism causing Respiratory Tract Infection
Time frame: 365 days
Level of protective antibody against influenza virus
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Inflammatory cytokine
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Protection against apoptosis and oxidative stress
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of lactoferrin
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of thiocyanate
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Salivary level of hypohalous acid
Time frame: Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Complete Blood Count
Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365
Comprehensive Metabolic Panel
Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365
Body Weight
Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365
Short Form (12) Health Survey Version 2 (SF-12v2®)
Time frame: Baseline, Day 45, Day 90, Day 180, and Day 365
Use of medical treatments
Time frame: 365 days
Medically confirmed Adverse Events
Time frame: 365 days
COVID Vaccine specific inflammatory panel
Time frame: Day 45, Day 90, Day 180, Day 270, and Day 365
Influenza Hemagglutination-inhibition Antibody Titer
Time frame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Cytokine Panel
Time frame: Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Wu, MD study director
Mead Johnson/RB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bovine lactoferrin supplement in people with Immune Health, run by Mead Johnson Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Respiratory Tract Infections (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.