Growth of Healthy Term Infants Fed Formula Containing DHA-B

DSM Nutritional Products, Inc.10 sites in 1 country159 target enrollmentMay 2014

ConditionsGrowth Tolerance Infant Development

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Growth
Sponsor: DSM Nutritional Products, Inc.
Enrollment: 159
Locations: 10
Primary Endpoint: weight gain (gm/day)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DSM Nutritional Products, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•full term infant (gestational age 37-42 weeks)
•birth weight \> or equal to 2500 g
•singleton infant \< or equal to 14 days of age in good health
•parent must be \>21 years of age
•parental consent

Exclusion Criteria

•congenital malformation or genetic disorder
•metabolic anomalies
•maternal infectious diseases, alcoholism, substance abuse
•mothers with gestational diabetes
•participation in another clinical study

Outcomes

Primary Outcomes

weight gain (gm/day)

Time Frame: through day of life 120

gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.