Growth of Healthy Term Infants Fed Formula Containing DHA-B

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02144402

Enrollment

159

Registered

2014-05-22

Start date

2014-05-31

Completion date

2015-07-31

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Infant Development, Tolerance

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.

Interventions

OTHERinfant formula with DHASCO

OTHERinfant formula with DHASCO-B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 14 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
length (cm)	through day of life 120	Length in cm
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
Formula intake and tolerance	Day of life 30 and 120	assessed by analyzing three-day dietary intake and tolerance forms

Other

Measure	Time frame	Description
adverse events	through day of life 120	AEs collected throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026