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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03828708
Other study ID # 18-1317
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date May 2024

Study information

Verified date February 2023
Source University of Colorado, Denver
Contact Minghua Tang, PhD
Phone 7653377572
Email minghua.tang@ucdenver.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 4 Months
Eligibility Inclusion Criteria: - Healthy new born infants Exclusion Criteria: - Newborn infants with conditions that prohibit cow-milk based formula consumption

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gut microbiota the gut microbial structure of the participants, by stool samples collected birth to 4 months of age
Secondary Iron status: soluble transferrin receptor Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency. at baseline (birth) and end of intervention (4 months)
Secondary Iron status: ferritin A ferritin blood test shows how much iron is stored in your body. at baseline (birth) and end of intervention (4 months)
Secondary Iron status: hepcidin Hepcidin is a regulator of iron metabolism. at baseline (birth) and end of intervention (4 months)
Secondary Inflammation: c-reactive protein C-reactive protein (CRP) is a substance produced by the liver in response to inflammation. at baseline (birth) and end of intervention (4 months)
Secondary Immunity: soluble CD14 biomarker of innate immunity at baseline (birth) and end of intervention (4 months)
Secondary Sleep patterns: duration Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration. end of intervention (4 months)
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