Early Iron Exposure on the Gut Microbiota in Young Infants

NCT03828708 | Unknown

• 1 other identifier: 18-1317
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  the gut microbial structure of the participants, by stool samples collected

  birth to 4 months of age

Secondary Outcomes (6)

• Iron status: soluble transferrin receptor

  at baseline (birth) and end of intervention (4 months)

• Iron status: ferritin

  at baseline (birth) and end of intervention (4 months)

• Iron status: hepcidin

  at baseline (birth) and end of intervention (4 months)

• Inflammation: c-reactive protein

  at baseline (birth) and end of intervention (4 months)

• Immunity: soluble CD14

  at baseline (birth) and end of intervention (4 months)

Study Arms (2)

Standard iron arm

EXPERIMENTAL

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

Low iron arm

EXPERIMENTAL

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

Interventions

Iron in infant formula OTHER

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.

Low iron arm; Standard iron arm

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy new born infants

You may not qualify if:

• Newborn infants with conditions that prohibit cow-milk based formula consumption

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Interventions

Iron; Infant Formula

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Minghua Tang, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghua Tang, PhD

CONTACT

7653377572; minghua.tang@ucdenver.edu

Julie Long, MS

CONTACT

303-724-9377; julie.long@ucdenver.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of the two groups with different amount of iron consumed.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 4, 2019
• Study Start: September 28, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

US (1)