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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02144402
Other study ID # 2013-1069
Secondary ID
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


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
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