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.)
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.
Study Type
OBSERVATIONAL
Enrollment
267
Asian Hospital and Medical Center
Filinvest Corporate City, Alabang,, Muntinlupa City, Philippines
Weight-for-Length Z-Scores
Primary Efficacy Endpoint: weight-for-length Z-score based on World Health Organization (WHO) growth charts.
Time frame: 2 years of age
Weight-for-age Z-score
Weight-for-age Z-score based on World Health Organization (WHO) growth charts
Time frame: 2 years of age
Length-for-age Z-score
Length-for-age Z-score based on World Health Organization (WHO) growth charts
Time frame: 2 years of age
Head circumference-for-age Z-score
Head circumference-for-age Z-score based on World Health Organization (WHO) growth charts
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 2 years of age
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