Growth of Healthy Term Infants Fed Formula Containing DHA-B

August 3, 2015 updated by: DSM Nutritional Products, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Claude Ashley, MD
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • JBRKIDS
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric
    • Florida
      • St Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance
      • Wellington, Florida, United States, 33414
        • Atlantic Clinical Research
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Pedia Research
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Heartland Research
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Stephen Kasparian
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • MCHRI
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Ohio Pediatric Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: infant formula with DHASCO
standard infant formula with docosahexaenoic acid (DHA)
Other: infant formula with DHASCO
EXPERIMENTAL: infant formula with DHASCO-B
standard infant formula with DHA-B
Other: infant formula with DHASCO-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through day of life 120

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: through day of life 120
AEs collected throughout the study
through day of life 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Nutritional Products, Inc.

Collaborators

Accelovance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (ESTIMATE)

May 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 3, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2013-1069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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