Infant Development Clinical Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
DSM Nutritional Products, Inc. | Accelovance |
United States,
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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