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OpenTrials
Completed

NCT Number: NCT05947084

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

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.

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Key information

Conditions

Infant Development

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Velocity Clinical Research-Phoenix, Phoenix, Arizona, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Term Infant

Exclusion criteria

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

Treatment and study plan

Infant Formula

Other

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

Primary outcomes

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

    Time frame: 16 weeks of Clinical Study

    Growth Monitoring Study

Secondary outcomes

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

    Time frame: 16 weeks of Clinical Study

    Growth Monitoring Study

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

    Time frame: 16 weeks of Clinical Study

    Growth Monitoring Study

  3. Tolerance of study formulas over 16 weeks of study

    Time frame: 16 weeks of Clinical Study

    Tolerance of the infant to the study formulas will be evaluated 5 times through the use of study diaries for 3 days before each study visit.

Sponsors and collaborators

Lead sponsor

Aussie Bubs, Inc.

Industry

Collaborators

  • Validcare

Registry information

Official study title

Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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