Infant Development
Conditions
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.
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.
Interventions
OTHERIron 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants will be randomized to one of the two groups with different amount of iron consumed.
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy new born infants
Exclusion criteria
* Newborn infants with conditions that prohibit cow-milk based formula consumption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota | birth to 4 months of age | the gut microbial structure of the participants, by stool samples collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron status: ferritin | at baseline (birth) and end of intervention (4 months) | A ferritin blood test shows how much iron is stored in your body. |
| Iron status: hepcidin | at baseline (birth) and end of intervention (4 months) | Hepcidin is a regulator of iron metabolism. |
| Iron status: soluble transferrin receptor | at baseline (birth) and end of intervention (4 months) | Soluble transferrin receptors are proteins found in blood that can be elevated with iron deficiency. |
| Immunity: soluble CD14 | at baseline (birth) and end of intervention (4 months) | biomarker of innate immunity |
| Sleep patterns: duration | end of intervention (4 months) | Participants will wear a device (Micro Motionlogger Watch version 734) to provide objective measurements of duration. |
| Inflammation: c-reactive protein | at baseline (birth) and end of intervention (4 months) | C-reactive protein (CRP) is a substance produced by the liver in response to inflammation. |
Countries
United States
Contacts
Primary ContactMinghua Tang, PhD
Backup ContactJulie Long, MS
Outcome results
None listed