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Early Iron Exposure on the Gut Microbiota in Young Infants (IF)

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ClinicalTrials.gov Identifier: NCT03828708
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This study will look at the amount of iron in infant formula and how that affects a child's gut development. The children of mothers who plan to formula feed their children will be randomized to receive either high iron or low iron formula from birth until 4 months of age. Infants will consume only the study provided formula during enrollment. Blood and stool samples will be collected at birth and end of study to measure the effects of the iron exposure. The overall object is to compare high iron versus low iron exposure in formula-fed infants during the first months of life. Aims include determining the types of bacteria that are present in the infants' fecal microbiome, determining the effect of high iron exposure on gut microbiome and sleep patterns, and comparing iron status and homeostasis between the low and high iron formula groups.

Condition or disease Intervention/treatment Phase
Infant Development Other: Iron in infant formula Not Applicable

Detailed Description:

Disturbance of the gut microbial colonization during infancy may result in long-term programming impact of metabolism and disease risks of the host. The early gut microbial colonization coincides with the maturation of the infant's mucosal innate immune system and research showed that the gut microbial dysbiosis is associated with impaired innate immune development. Thus, ensuring proper microbial colonization early in life is critical to the maturation of the immune system and long-term health.

Iron fortification can increase the abundance of pathogenic bacteria and induce inflammation in older infants. However, it is still not known what the effect of iron is on a more vulnerable population: the newborn infant, who has immature immune system. Infants 0-4 months are at a low risk for iron deficiency due to the iron endowment at birth, which is compatible with the very low iron content (<0.5mg Fe/L) in breastmilk. However, commercial infant formulas are all fortified with ≥12mg Fe/L. Whether this striking difference drives adverse health effects is unknown/unexamined, especially on early colonization and immune homeostasis. The overall objective is to determine the impact of high vs. low iron exposure in formula-fed infants during the early post-natal months on gut microbiome.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of the two groups with different amount of iron consumed.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Different Iron Exposure on the Development of Gut Microbiota From Birth to Four Months
Actual Study Start Date : September 28, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard iron arm
Participants randomized to this arm will consume infant formula containing 12 mg/L of iron, equivalent to the standard iron content in U.S. infant formula
 Other: Iron in infant formula
Participants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L.
Experimental: Low iron arm
Participants randomized to this arm will consume infant formula containing 5 mg/L of iron, equivalent to the standard iron content in European infant formula
 Other: Iron in infant formula
Participants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L.


Outcome Measures
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Primary Outcome Measures :
  1. Gut microbiota [ Time Frame: birth to 4 months of age ]
    the gut microbial structure of the participants, by stool samples collected


Secondary Outcome Measures :
  1. Iron status: soluble transferrin receptor [ Time Frame: at baseline (birth) and end of intervention (4 months) ]
    Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency.

  2. Iron status: ferritin [ Time Frame: at baseline (birth) and end of intervention (4 months) ]
    A ferritin blood test shows how much iron is stored in your body.

  3. Iron status: hepcidin [ Time Frame: at baseline (birth) and end of intervention (4 months) ]
    Hepcidin is a regulator of iron metabolism.

  4. Inflammation: c-reactive protein [ Time Frame: at baseline (birth) and end of intervention (4 months) ]
    C-reactive protein (CRP) is a substance produced by the liver in response to inflammation.

  5. Immunity: soluble CD14 [ Time Frame: at baseline (birth) and end of intervention (4 months) ]
    biomarker of innate immunity

  6. Sleep patterns: duration [ Time Frame: end of intervention (4 months) ]
    Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration.


Eligibility Criteria
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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy new born infants

Exclusion Criteria:

  • Newborn infants with conditions that prohibit cow-milk based formula consumption
Contacts and Locations
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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): NCT03828708


Contacts
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Contact: Minghua Tang, PhD 7653377572 minghua.tang@ucdenver.edu
Contact: Julie Long, MS 303-724-9377 julie.long@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Minghua Tang, PhD    303-724-3248    minghua.tang@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Minghua Tang, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03828708    
Other Study ID Numbers: 18-1317
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the gut microbiome sequencing data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No