Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT02103205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D007781', 'term': 'Lactoferrin'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lactoferrin in breastmilk', 'timeFrame': 'At baseline, 4 and 6 months of age', 'description': 'Analyzed from mothers to the control group of breast fed infants.'}], 'primaryOutcomes': [{'measure': 'Incidence of infections', 'timeFrame': 'Up to 12 months of age', 'description': 'Morbidity journal, Health questionnaire'}, {'measure': 'Cytokine levels', 'timeFrame': 'At 6 months of age', 'description': 'IL-2, TNF-alpha'}, {'measure': 'Iron status', 'timeFrame': 'At 6 months of age', 'description': 's-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb'}], 'secondaryOutcomes': [{'measure': 'Dietary intake', 'timeFrame': 'At baseline, 3, 4, 5, 6 and 12 months of age', 'description': 'Dietary journal'}, {'measure': 'Growth', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age', 'description': 'Anthropometric data, Body Composition (PeaPod)'}, {'measure': 'Bloodpressure', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age'}, {'measure': 'Antibody response to vaccines', 'timeFrame': 'At baseline, 4, 6 and 12 months of age', 'description': 's-levels of specific antibodies to vaccines (DTP, Hib, PC)'}, {'measure': 'Gut microbiota', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age', 'description': 'Stool samples'}, {'measure': 'Saliva proteins', 'timeFrame': 'At 4 months of age', 'description': 'Saliva total protein content, lactoferrin, saliva-peroxidase, IgA and amylase'}, {'measure': 'Inflammatory markers', 'timeFrame': 'At baseline, 4, 6 and 12 months of age and 6 years age', 'description': 's-hsCRP, s-calprotectin'}, {'measure': 'Cognitive development and behavior', 'timeFrame': 'At 1 and 6 years of age', 'description': 'Bayley III, Wechsler Intelligence Scale for Children (WISC), Behavioral questionnaire'}, {'measure': 's-hepcidin', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age'}, {'measure': 'Metabolomics', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age', 'description': 'Analyzed in urine and serum samples'}, {'measure': 'Amino acids', 'timeFrame': 'At 4 and 6 months of age', 'description': 'p-amino acids'}, {'measure': 'Blood urea nitrogen', 'timeFrame': 'At 4 and 6 months of age', 'description': 'p-urea nitrogen'}, {'measure': 'Cytokine levels', 'timeFrame': 'At baseline, 4, 6, 12 months of age and 6 years of age', 'description': 'IL-2 and TNF alpha at baseline, 4 and 12 months of age and 6 years of age. Six additional cytokines at baseline, 4, 6 and 12 months of age and 6 years of age.'}, {'measure': 'Iron status', 'timeFrame': 'At baseline, 4 and 12 months of age and 6 years of age', 'description': 's-ferritin, s-transferrin, s-iron, s-transferrin saturation, s-transferrin receptor concentration, retuiculocyte Hb'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lactoferrin', 'Infant formula', 'Iron'], 'conditions': ['Health of Formula-fed Children', 'Infant Infections in Formula-fed Children', 'Iron Status of Formula-fed Children']}, 'referencesModule': {'references': [{'pmid': '34908015', 'type': 'DERIVED', 'citation': 'Bjormsjo M, Hernell O, Lonnerdal B, Berglund SK. Immunological Effects of Adding Bovine Lactoferrin and Reducing Iron in Infant Formula: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2022 Mar 1;74(3):e65-e72. doi: 10.1097/MPG.0000000000003367.'}]}, 'descriptionModule': {'briefSummary': 'Breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed.\n\nThe first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant formula. The general hypothesis is that bovine lactoferrin reduces some of the previously observed differences between formula-fed and breast-fed infants with regard to health and development. The main outcome studied is the effect on immune function. The second aim is to study the effects of lower iron concentration in infant formula and to test the hypothesis that iron can be lowered without negative effects on health and development. The main outcome studied here is iron status. Other outcomes in this trial are microbiota composition, metabolomics, growth, body composition and cognitive development.\n\nTo test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron (2 mg/L) control formula, or the same formula supplemented with bovine lactoferrin. To test the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher iron concentration (8 mg/L). Group allocation for all formula-fed infants will be double-blind randomized. Additionally, breast-fed infants will be recruited and used as a reference group (gold standard).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '4 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFormula-fed healthy infants at 6 +/- 2 weeks of age with:\n\n* birth weight 2500-4500 g\n* gestational age at birth ≥ 37 completed weeks\n* no chronic disease or neonatal diagnoses believed to affect any outcome\n* no given blood transfusions or iron supplements\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02103205', 'acronym': 'LIME', 'briefTitle': 'Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function', 'orgStudyIdInfo': {'id': 'LIME2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low iron, with lactoferrin', 'description': 'Low iron, with lactoferrin', 'interventionNames': ['Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low iron, no lactoferrin', 'description': 'Low iron, no lactoferrin', 'interventionNames': ['Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal iron, no lactoferrin', 'description': 'Normal iron, no lactoferrin', 'interventionNames': ['Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin']}], 'interventions': [{'name': 'Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low iron, with lactoferrin']}, {'name': 'Formula with low iron concentration (2mg/L) without lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low iron, no lactoferrin']}, {'name': 'Formula with normal iron concentration (8 mg/L) without lactoferrin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Normal iron, no lactoferrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-901 87', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University, Department of Clinical Sciences', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Staffan K Berglund, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}, {'name': 'Olle Hernell, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University'}, {'name': 'Bo Lönnerdal, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California'}, {'name': 'Carolyn Slupsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California', 'class': 'OTHER'}, {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Staffan Berglund', 'investigatorAffiliation': 'Umeå University'}}}}