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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Infant Development

Intervention / Treatment
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* Other: Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Term Infant Exclusion Criteria: Any health condition that would negatively impact infant feeding and growth.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization and exclusive feeding of study formulas by 14 days of age. Breastfed Cohort will be evaluated over the 16 weeks.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Formula 1_365 Day Grass-Fed Cow's Milk Infant Formula<br>Infant formula meets all nutrient requirements of the FDA. | Other: Infant Formula<br>* Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period<br>|
| Experimental: Study Formula 2_Goat Milk Infant Formula<br>Infant Formula meets all nutrient requirements of the FDA. | Other: Infant Formula<br>* Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period<br>|
| Experimental: Study Formula 3_Cow's Milk Infant Formula void of A1-BetaCasein<br>Infant Formula meets all nutrient requirements of the FDA. | Other: Infant Formula<br>* Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period<br>|
| Active Comparator: Study Formula 4_USDA Organic iron fortified infant formula<br>Infant Formula meets all nutrient requirements of the FDA. | Other: Infant Formula<br>* Growth Monitoring Study of Infant Formula fed to Healthy Term Infants over a 16 week period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain (g) from study entry to 16 weeks of study. | Growth Monitoring Study | 16 weeks of Clinical Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recumbent length gain (cm) from study entry to 16 weeks of study. | Growth Monitoring Study | 16 weeks of Clinical Study | 
| Head Circumference gain (cm) from study entry to 16 weeks of study | Growth Monitoring Study | 16 weeks of Clinical Study | 
| Tolerance of study formulas over 16 weeks of 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. | 16 weeks of Clinical Study |