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The trial is taking place at:
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Hightower Clinical | Oklahoma City, OK

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

Aussie Bubs logo

Aussie Bubs

Status and phase

Enrolling
Phase 3

Conditions

Infant Development

Treatments

Other: Infant Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT05947084
BubsGMS_2023

Details and patient eligibility

About

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.

Full description

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

Enrollment

440 estimated patients

Sex

All

Ages

1 to 14 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy Term Infant

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

440 participants in 4 patient groups

Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula
Experimental group
Description:
Infant formula meets all nutrient requirements of the FDA.
Treatment:
Other: Infant Formula
Study Formula 2_Goat Milk Infant Formula
Experimental group
Description:
Infant Formula meets all nutrient requirements of the FDA.
Treatment:
Other: Infant Formula
Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein
Experimental group
Description:
Infant Formula meets all nutrient requirements of the FDA.
Treatment:
Other: Infant Formula
Study Formula 4_USDA Organic iron fortified infant formula
Active Comparator group
Description:
Infant Formula meets all nutrient requirements of the FDA.
Treatment:
Other: Infant Formula

Trial contacts and locations

35

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Central trial contact

Patrick McCarthy, JD; Keith A Aqua, MD

Data sourced from clinicaltrials.gov

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