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

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

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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