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

NCT05947084 | Completed DMC

• 1 other identifier: BubsGMS_2023
• Study Type: interventional
• Target: 518
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (1)

• Weight gain (g) from study entry to 16 weeks of study.

  Growth Monitoring Study

  16 weeks of Clinical Study

Secondary Outcomes (3)

• Recumbent length gain (cm) from study entry to 16 weeks of study.

  16 weeks of Clinical Study

• Head Circumference gain (cm) from study entry to 16 weeks of study

  16 weeks of Clinical Study

• Tolerance of study formulas over 16 weeks of study

  16 weeks of Clinical Study

Study Arms (4)

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

EXPERIMENTAL

Infant formula meets all nutrient requirements of the FDA.

Other: Infant Formula

Study Formula 2_Goat Milk Infant Formula

EXPERIMENTAL

Infant Formula meets all nutrient requirements of the FDA.

Other: Infant Formula

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

EXPERIMENTAL

Infant Formula meets all nutrient requirements of the FDA.

Other: Infant Formula

Study Formula 4_USDA Organic iron fortified infant formula

ACTIVE COMPARATOR

Infant Formula meets all nutrient requirements of the FDA.

Other: Infant Formula

Interventions

Infant Formula OTHER

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

Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula; Study Formula 2_Goat Milk Infant Formula; Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein; Study Formula 4_USDA Organic iron fortified infant formula

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Term Infant

You may not qualify if:

• Any health condition that would negatively impact infant feeding and growth.

Sponsors & Collaborators

• Aussie Bubs, Inc.: lead
• Validcare: collaborator

Study Sites (29)

Velocity Clinical Research-Phoenix

Phoenix, Arizona, 85006, United States

Location

Advance Pediatric Associates

Centennial, Colorado, 80015, United States

Location

Symphony Clinical Research

Jacksonville, Florida, 32216, United States

Location

Clintheory Healthcare Miami

North Miami Beach, Florida, 33162, United States

Location

PAS Research Tampa

Tampa, Florida, 33607, United States

Location

UpTo Trials

Tampa, Florida, 33612, United States

Location

Backtee Holdings, LLC

Wellington, Florida, 33414, United States

Location

Velocity Clinical Research-Macon

Macon, Georgia, 31210, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Kentucky Pediatric Research

Bardstown, Kentucky, 40004, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Magnolia Clinical Research, LLC

Lutcher, Louisiana, 70071, United States

Location

Velocity Clinical Research-Slidell, LA

Slidell, Louisiana, 70458, United States

Location

Frontier Pediatric Research, LLC

Lincoln, Nebraska, 68516, United States

Location

PAS Research Henderson

Henderson, Nevada, 89014, United States

Location

PAS Research Vegas

Las Vegas, Nevada, 89128, United States

Location

Velocity Clinical Research-Durham

Durham, North Carolina, 27701, United States

Location

Hightower Clinical-Oklahoma City

Oklahoma City, Oklahoma, 73114, United States

Location

Hightower Clinical-Shawnee

Shawnee, Oklahoma, 74804, United States

Location

Cyn3rgy

Gresham, Oregon, 97030, United States

Location

PAS Pittsburgh

Pittsburgh, Pennsylvania, 15227, United States

Location

Coastal Ped Research-Charleston

Charleston, South Carolina, 29414, United States

Location

Coastal Ped Research-Summerville

Summerville, South Carolina, 29486, United States

Location

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, 38115, United States

Location

Helios Clinical Research-Burleson

Burleson, Texas, 76028, United States

Location

Helios Clinical Research-Houston

Houston, Texas, 77008, United States

Location

Prime Clinical Research, Inc

Mansfield, Texas, 76063, United States

Location

PAS Research McAllen

McAllen, Texas, 78504, United States

Location

Helios Clinical Research-Weatherford

Weatherford, Texas, 76086, United States

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Keith Aqua, MD

  Backtee Holdings, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study infant formulas have been blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 17, 2023
• Study Start: August 31, 2023
• Primary Completion: April 19, 2025
• Study Completion: June 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)