Growth of Healthy Term Infants Fed Formula Containing DHA-B
1 other identifier
interventional
159
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 4, 2015
August 1, 2015
1.2 years
May 16, 2014
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
length (cm)
through day of life 120
head circumference (cm)
through day of life 120
fatty acid levels (wgt %)
at day of life 120
Formula intake and tolerance
Day of life 30 and 120
Other Outcomes (1)
adverse events
through day of life 120
Study Arms (2)
infant formula with DHASCO
ACTIVE COMPARATORstandard infant formula with docosahexaenoic acid (DHA)
infant formula with DHASCO-B
EXPERIMENTALstandard infant formula with DHA-B
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- congenital malformation or genetic disorder
- metabolic anomalies
- maternal infectious diseases, alcoholism, substance abuse
- mothers with gestational diabetes
- participation in another clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DSM Nutritional Products, Inc.lead
- Accelovancecollaborator
Study Sites (10)
Claude Ashley, MD
Dothan, Alabama, 36305, United States
JBRKIDS
Jonesboro, Arkansas, 72401, United States
Norwich Pediatric
Norwich, Connecticut, 06360, United States
Score Physician Alliance
St. Petersburg, Florida, 33710, United States
Atlantic Clinical Research
Wellington, Florida, 33414, United States
Pedia Research
Newburgh, Indiana, 47630, United States
Heartland Research
Wichita, Kansas, 67205, United States
Stephen Kasparian
Fall River, Massachusetts, 02720, United States
MCHRI
Lincoln, Nebraska, 68504, United States
Ohio Pediatric Research
Dayton, Ohio, 45414, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2014
First Posted
May 22, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 4, 2015
Record last verified: 2015-08