Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas

NCT ID: NCT05947084

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Study infant formulas have been blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula

Infant formula meets all nutrient requirements of the FDA.

Group Type EXPERIMENTAL

Infant Formula

Intervention Type OTHER

Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Study Formula 2_Goat Milk Infant Formula

Infant Formula meets all nutrient requirements of the FDA.

Group Type EXPERIMENTAL

Infant Formula

Intervention Type OTHER

Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein

Infant Formula meets all nutrient requirements of the FDA.

Group Type EXPERIMENTAL

Infant Formula

Intervention Type OTHER

Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Study Formula 4_USDA Organic iron fortified infant formula

Infant Formula meets all nutrient requirements of the FDA.

Group Type ACTIVE_COMPARATOR

Infant Formula

Intervention Type OTHER

Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Infant Formula

Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy Term Infant

Exclusion Criteria

* Any health condition that would negatively impact infant feeding and growth.
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Validcare

UNKNOWN

Sponsor Role collaborator

Aussie Bubs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Keith Aqua, MD

Role: PRINCIPAL_INVESTIGATOR

Backtee Holdings, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Velocity Clinical Research-Phoenix

Phoenix, Arizona, United States

Site Status

Advance Pediatric Associates

Centennial, Colorado, United States

Site Status

Symphony Clinical Research

Jacksonville, Florida, United States

Site Status

Clintheory Healthcare Miami

North Miami Beach, Florida, United States

Site Status

PAS Research Tampa

Tampa, Florida, United States

Site Status

UpTo Trials

Tampa, Florida, United States

Site Status

Backtee Holdings, LLC

Wellington, Florida, United States

Site Status

Velocity Clinical Research-Macon

Macon, Georgia, United States

Site Status

Leavitt Clinical Research

Idaho Falls, Idaho, United States

Site Status

Kentucky Pediatric Research

Bardstown, Kentucky, United States

Site Status

Springs Medical Research

Owensboro, Kentucky, United States

Site Status

Magnolia Clinical Research, LLC

Lutcher, Louisiana, United States

Site Status

Velocity Clinical Research-Slidell, LA

Slidell, Louisiana, United States

Site Status

Frontier Pediatric Research, LLC

Lincoln, Nebraska, United States

Site Status

PAS Research Henderson

Henderson, Nevada, United States

Site Status

PAS Research Vegas

Las Vegas, Nevada, United States

Site Status

Velocity Clinical Research-Durham

Durham, North Carolina, United States

Site Status

Hightower Clinical-Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Hightower Clinical-Shawnee

Shawnee, Oklahoma, United States

Site Status

Cyn3rgy

Gresham, Oregon, United States

Site Status

PAS Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Coastal Ped Research-Charleston

Charleston, South Carolina, United States

Site Status

Coastal Ped Research-Summerville

Summerville, South Carolina, United States

Site Status

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, United States

Site Status

Helios Clinical Research-Burleson

Burleson, Texas, United States

Site Status

Helios Clinical Research-Houston

Houston, Texas, United States

Site Status

Prime Clinical Research, Inc

Mansfield, Texas, United States

Site Status

PAS Research McAllen

McAllen, Texas, United States

Site Status

Helios Clinical Research-Weatherford

Weatherford, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BubsGMS_2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preterm Infants Fed a Human Milk Fortifier
NCT05551975 NOT_YET_RECRUITING NA
Preterm Infant Growth
NCT01162798 COMPLETED NA