Clinical trial NCT02010749: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Official title: Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bottle Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-12-13
Enrollment: 267
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children 2 years of age who were enrolled in the Wyeth Nutrition study

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight-for-Length Z-Scores
timeFrame: 2 years of age
Secondary outcomes:
measure: Weight-for-age Z-score
timeFrame: 2 years of age
measure: Length-for-age Z-score
timeFrame: 2 years of age
measure: Head circumference-for-age Z-score
timeFrame: 2 years of age
measure: BMI-for-age Z-score
timeFrame: 2 years of age
measure: Dietary intake
timeFrame: 2 years of age
measure: Nutrient intake
timeFrame: 2 years of age
Other outcomes:
measure: Stool microbiota Follow-up Study of Growth at 2 Years of Age
timeFrame: 2 years of age
measure: Stool composition
timeFrame: 2 years of age
measure: Incidence of adverse events
timeFrame: 2 years of age
Locations:
city: Filinvest Corporate City, Alabang,
country: Philippines
facility: Asian Hospital and Medical Center
state: Muntinlupa City
Study officials:
References: