Growth of Healthy Term Infants Fed Formula Containing DHA-B

Not Applicable

Completed

• Conditions: Tolerance; Infant Development; Growth
• Interventions: Other: infant formula with DHASCO; Other: infant formula with DHASCO-B

• Registration Number: NCT02144402
• Lead Sponsor: DSM Nutritional Products, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-22
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infant formula with DHASCO	infant formula with DHASCO	standard infant formula with docosahexaenoic acid (DHA)
infant formula with DHASCO-B	infant formula with DHASCO-B	standard infant formula with DHA-B

Primary Outcome Measures

Name	Time	Method
weight gain (gm/day)	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.

Secondary Outcome Measures

Name	Time	Method
Formula intake and tolerance	Day of life 30 and 120	assessed by analyzing three-day dietary intake and tolerance forms
head circumference (cm)	through day of life 120	head circumference (cm)
fatty acid levels (wgt %)	at day of life 120	red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset
length (cm)	through day of life 120	Length in cm

Trial Locations

Locations (10)

Ohio Pediatric Research; 🇺🇸 Dayton, Ohio, United States

Heartland Research; 🇺🇸 Wichita, Kansas, United States

Claude Ashley, MD; 🇺🇸 Dothan, Alabama, United States

JBRKIDS; 🇺🇸 Jonesboro, Arkansas, United States

Atlantic Clinical Research; 🇺🇸 Wellington, Florida, United States

Norwich Pediatric; 🇺🇸 Norwich, Connecticut, United States

Score Physician Alliance; 🇺🇸 St Petersburg, Florida, United States

Pedia Research; 🇺🇸 Newburgh, Indiana, United States

Stephen Kasparian; 🇺🇸 Fall River, Massachusetts, United States

MCHRI; 🇺🇸 Lincoln, Nebraska, United States