Growth of Healthy Term Infants Fed Formula Containing DHA-B

Infant Development Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144402
• Other study ID #: 2013-1069
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: August 3, 2015
• Start date: May 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth
• Infant Development
• Tolerance

Intervention

Other:
• infant formula with DHASCO

• infant formula with DHASCO-B

Locations

Country	Name	City	State
United States	Ohio Pediatric Research	Dayton	Ohio
United States	Claude Ashley, MD	Dothan	Alabama
United States	Stephen Kasparian	Fall River	Massachusetts
United States	JBRKIDS	Jonesboro	Arkansas
United States	MCHRI	Lincoln	Nebraska
United States	Pedia Research	Newburgh	Indiana
United States	Norwich Pediatric	Norwich	Connecticut
United States	Score Physician Alliance	St Petersburg	Florida
United States	Atlantic Clinical Research	Wellington	Florida
United States	Heartland Research	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Accelovance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	AEs collected throughout the study	through day of life 120	Yes
Primary	weight gain (gm/day)	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.	through day of life 120	No
Secondary	length (cm)	Length in cm	through day of life 120	No
Secondary	head circumference (cm)	head circumference (cm)	through day of life 120	No
Secondary	fatty acid levels (wgt %)	red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset	at day of life 120	No
Secondary	Formula intake and tolerance	assessed by analyzing three-day dietary intake and tolerance forms	Day of life 30 and 120	No