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

Sponsor
Aussie Bubs, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05947084
Collaborator
(none)
440
Enrollment
4
Arms
13.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Infant Formula
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization and exclusive feeding of study formulas by 14 days of age.Randomization and exclusive feeding of study formulas by 14 days of age.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study infant formulas have been blinded
Primary Purpose:
Other
Official Title:
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Aug 9, 2024
Anticipated Study Completion Date :
Sep 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula

Infant formula meets all nutrient requirements of the FDA.

Other: Infant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Experimental: Study Formula 2_Goat Milk Infant Formula

Infant Formula meets all nutrient requirements of the FDA.

Other: Infant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Experimental: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein

Infant Formula meets all nutrient requirements of the FDA.

Other: Infant Formula
Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period
Active Comparator: Study Formula 4_USDA Organic iron fortified infant formula

Infant Formula meets all nutrient requirements of the FDA.

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

Outcome Measures

Primary Outcome Measures

  1. Weight gain (g) from study entry to 16 weeks of study. [16 weeks of Clinical Study]

    Growth Monitoring Study

Secondary Outcome Measures

  1. Recumbent length gain (cm) from study entry to 16 weeks of study. [16 weeks of Clinical Study]

    Growth Monitoring Study

  2. Head Circumference gain (cm) from study entry to 16 weeks of study [16 weeks of Clinical Study]

    Growth Monitoring Study

  3. Tolerance of study formulas over 16 weeks of study [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 14 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy Term Infant
Exclusion Criteria:
  • Any health condition that would negatively impact infant feeding and growth.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Aussie Bubs, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aussie Bubs, Inc.
ClinicalTrials.gov Identifier:
NCT05947084
Other Study ID Numbers:
  • BubsGMS_2023
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 19, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 19, 2023