Growth of Healthy Term Infants Fed Formula Containing DHA-B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Tolerance Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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infant formula with DHASCO

standard infant formula with docosahexaenoic acid (DHA)

Group Type ACTIVE_COMPARATOR

infant formula with DHASCO

Intervention Type OTHER

infant formula with DHASCO-B

standard infant formula with DHA-B

Group Type EXPERIMENTAL

infant formula with DHASCO-B

Intervention Type OTHER

Interventions

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infant formula with DHASCO

Intervention Type OTHER

infant formula with DHASCO-B

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes