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Trial record 1 of 2362 for:    infant health
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Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function (LIME)

This study is currently recruiting participants.
Verified October 2016 by Staffan Berglund, Umeå University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02103205
First Posted: April 3, 2014
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of California
Mead Johnson Nutrition
Information provided by (Responsible Party):
Staffan Berglund, Umeå University
  Purpose

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.

The 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.

To 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).


Condition Intervention
Health of Formula-fed Children Infant Infections in Formula-fed Children Iron Status of Formula-fed Children Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function

Resource links provided by NLM:


Further study details as provided by Staffan Berglund, Umeå University:

Primary Outcome Measures:
  • Incidence of infections [ Time Frame: Up to 12 months of age ]
    Morbidity journal, Health questionnaire

  • Cytokine levels [ Time Frame: At 6 months of age ]
    IL-2, TNF-alpha

  • Iron status [ Time Frame: At 6 months of age ]
    s-ferritin, s-transferrin, s-iron, s-transferrin receptor concentration, reticulocyte Hb


Secondary Outcome Measures:
  • Dietary intake [ Time Frame: At baseline, 3, 4, 5, 6 and 12 months of age ]
    Dietary journal

  • Growth [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
    Anthropometric data, Body Composition (PeaPod)

  • Bloodpressure [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
  • Antibody response to vaccines [ Time Frame: At baseline, 4, 6 and 12 months of age ]
    s-levels of specific antibodies to vaccines (DTP, Hib, PC)

  • Gut microbiota [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
    Stool samples

  • Saliva proteins [ Time Frame: At 4 months of age ]
    Saliva total protein content, lactoferrin, saliva-peroxidase, IgA and amylase

  • Inflammatory markers [ Time Frame: At baseline, 4, 6 and 12 months of age and 6 years age ]
    s-hsCRP, s-calprotectin

  • Cognitive development and behavior [ Time Frame: At 1 and 6 years of age ]
    Bayley III, Wechsler Intelligence Scale for Children (WISC), Behavioral questionnaire

  • s-hepcidin [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
  • Metabolomics [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
    Analyzed in urine and serum samples

  • Amino acids [ Time Frame: At 4 and 6 months of age ]
    p-amino acids

  • Blood urea nitrogen [ Time Frame: At 4 and 6 months of age ]
    p-urea nitrogen

  • Cytokine levels [ Time Frame: At baseline, 4, 6, 12 months of age and 6 years of age ]
    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.

  • Iron status [ Time Frame: At baseline, 4 and 12 months of age and 6 years of age ]
    s-ferritin, s-transferrin, s-iron, s-transferrin saturation, s-transferrin receptor concentration, retuiculocyte Hb


Other Outcome Measures:
  • Lactoferrin in breastmilk [ Time Frame: At baseline, 4 and 6 months of age ]
    Analyzed from mothers to the control group of breast fed infants.


Estimated Enrollment: 252
Study Start Date: June 2014
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low iron, with lactoferrin
Low iron, with lactoferrin
Dietary Supplement: Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin
Active Comparator: Low iron, no lactoferrin
Low iron, no lactoferrin
Dietary Supplement: Formula with low iron concentration (2mg/L) without lactoferrin
Placebo Comparator: Normal iron, no lactoferrin
Normal iron, no lactoferrin
Dietary Supplement: Formula with normal iron concentration (8 mg/L) without lactoferrin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Formula-fed healthy infants at 6 +/- 2 weeks of age with:

  • birth weight 2500-4500 g
  • gestational age at birth ≥ 37 completed weeks
  • no chronic disease or neonatal diagnoses believed to affect any outcome
  • no given blood transfusions or iron supplements

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103205


Contacts
Contact: Staffan K Berglund, MD, PhD +46907852370 staffan.berglund@pediatri.umu.se

Locations
Sweden
Umeå University, Department of Clinical Sciences Recruiting
Umeå, Sweden, SE-901 87
Contact: Staffan K Berglund, MD, PhD    +46907852370    staffan.berglund@pediatri.umu.se   
Principal Investigator: Staffan K Berglund, MD, PhD         
Principal Investigator: Olle Hernell, Professor         
Sub-Investigator: Maria Björmsjö, MD         
Sponsors and Collaborators
Umeå University
University of California
Mead Johnson Nutrition
Investigators
Principal Investigator: Staffan K Berglund, MD, PhD Umeå University
Principal Investigator: Olle Hernell, Professor Umeå University
Principal Investigator: Bo Lönnerdal, Professor University of California
Principal Investigator: Carolyn Slupsky, PhD University of California
  More Information

Responsible Party: Staffan Berglund, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT02103205     History of Changes
Other Study ID Numbers: LIME2014
First Submitted: March 31, 2014
First Posted: April 3, 2014
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Staffan Berglund, Umeå University:
Lactoferrin
Infant formula
Iron

Additional relevant MeSH terms:
Iron
Lactoferrin
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Infective Agents