Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

Study Overview
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Brief Summary
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The primary objective of the study was to compare the growth parameters of children approximately 2* years of age, who as infants were randomized to receive either a lower-protein formula (experimental formula; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort. (* The mean age of subjects was 33.0 months due to a delay in the study start-up.)

Detailed Description
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This was an observational, single-site, follow-up study of healthy children who as infants who had completed study 9052A1-3000. An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001. Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies, respectively.

Official Title
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Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

Conditions
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Bottle Feeding

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who were enrolled in the Wyeth Nutrition study are eligible to participate in this study Exclusion Criteria: Children who were not enrolled in the Wyeth Nutrition study are not eligible to participate in this study Children who have received any antibiotics and antifungal medications except topical within two weeks prior to enrollment are not eligible to participate in the stool microbiota study Children who are taking any medications known or suspected to affect fat digestion, absorption, and or metabolism, any vitamin and or mineral supplements which contain calcium, suppositories, bismuth-containing medications, herbal supplements, or medications that may neutralize or suppress gastric acid secretion, are not eligible to participate in the stool composition study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Control: Children who had received Standard formula (SF) as infants | |
| Experimental<br>Experimental: Children who had received lower protein formula as infants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-for-Length Z-Scores | Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts. | 2 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-for-age Z-score | Weight-for-age Z-score based on World Health Organization (WHO) growth charts | 2 years of age | 
| Length-for-age Z-score | Length-for-age Z-score based on World Health Organization (WHO) growth charts | 2 years of age | 
| Head circumference-for-age Z-score | Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts | 2 years of age | 
| BMI-for-age Z-score | BMI-for-age Z-score based on WHO and Centers for Disease Control (CDC) growth charts | 2 years of age | 
| Dietary intake | Dietary intake (servings per day), percent contribution to energy intake, and percent contribution to protein intake of Dietary endpoints included mean intake (servings per day), percentage contribution to energy intake, and percentage contribution to protein intake of: Cereal/cereal products Starchy roots/tubers Sugars/syrups Fats/oils Fish/meat/poultry Eggs Milk and milk products Dried beans/nuts/seeds Vegetables Fruits Miscellaneous foods | 2 years of age | 
| Nutrient intake | Nutrition endpoints included mean intake and percentage adequacy based on the recommended intake of: Total energy (kcal) Protein (g) Carbohydrates (g) (mean intake only) Fat (g) (mean intake only) Iron (mg) Retinol equivalents (μg) Calcium (g) Thiamin (mg) Riboflavin (mg) Niacin (mg) Ascorbic acid (mg) Iodine (μg) Vitamin D (μg) Zinc (μg) | 2 years of age |