Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 7:19 PM
Study NCT ID:
NCT04713735
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2021-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Respiratory Tract Infections', 'timeFrame': '365 days'}], 'secondaryOutcomes': [{'measure': 'Severity of Respiratory Tract Infection', 'timeFrame': '365 days', 'description': 'Mild, Moderate, or Severe rating'}, {'measure': 'Duration of Respiratory Tract Infection', 'timeFrame': '365 days'}, {'measure': 'Number of Respiratory Tract Infections', 'timeFrame': '180 days'}, {'measure': 'Treatment of Respiratory Tract Infections', 'timeFrame': '365 days'}, {'measure': 'Complications from Respiratory Tract Infections', 'timeFrame': '365 days'}, {'measure': 'Microorganism causing Respiratory Tract Infection', 'timeFrame': '365 days'}, {'measure': 'Level of protective antibody against influenza virus', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Inflammatory cytokine', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Protection against apoptosis and oxidative stress', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Salivary level of lactoferrin', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Salivary level of thiocyanate', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Salivary level of hypohalous acid', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365'}, {'measure': 'Complete Blood Count', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, and Day 365'}, {'measure': 'Comprehensive Metabolic Panel', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, and Day 365'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, and Day 365'}, {'measure': 'Short Form (12) Health Survey Version 2 (SF-12v2®)', 'timeFrame': 'Baseline, Day 45, Day 90, Day 180, and Day 365'}, {'measure': 'Use of medical treatments', 'timeFrame': '365 days'}, {'measure': 'Medically confirmed Adverse Events', 'timeFrame': '365 days'}, {'measure': 'COVID Vaccine specific inflammatory panel', 'timeFrame': 'Day 45, Day 90, Day 180, Day 270, and Day 365', 'description': 'IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines'}, {'measure': 'Influenza Hemagglutination-inhibition Antibody Titer', 'timeFrame': 'Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28'}, {'measure': 'Cytokine Panel', 'timeFrame': 'Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Health']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 55 years of age at time of consent\n* Able to eat and drink, with assistance if required\n* Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study\n* Signed consent obtained from subject or legally authorized representative\n* Signed authorization obtained to use and/or disclose Protected Health Information\n\nExclusion Criteria:\n\n* Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition\n* Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation\n* 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\n* Known allergy or intolerance to study products\n* On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months\n* Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration\n* Have experienced Respiratory Tract Infection within 1 week prior to randomization'}, 'identificationModule': {'nctId': 'NCT04713735', 'briefTitle': 'Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population', 'orgStudyIdInfo': {'id': '3393-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control: Placebo', 'description': 'Control: Placebo', 'interventionNames': ['Dietary Supplement: Control: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Investigational: 600 mg bovine lactoferrin supplement', 'description': 'Investigational: 600 mg bovine lactoferrin supplement', 'interventionNames': ['Dietary Supplement: bovine lactoferrin supplement']}], 'interventions': [{'name': 'Control: Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Control: Placebo']}, {'name': 'bovine lactoferrin supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '600 mg', 'armGroupLabels': ['Investigational: 600 mg bovine lactoferrin supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Steven Wu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson/RB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}