Growth of Healthy Term Infants Fed Formula Containing DHA-B

DSM Nutritional Products

Status: Completed

Conditions: Tolerance; Infant Development; Growth

Treatments: Other: infant formula with DHASCO-B; Other: infant formula with DHASCO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02144402

2013-1069

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups

infant formula with DHASCO

Active Comparator group

Description:

standard infant formula with docosahexaenoic acid (DHA)

Treatment:

Other: infant formula with DHASCO

infant formula with DHASCO-B

Experimental group

Description:

standard infant formula with DHA-B

Treatment:

Other: infant formula with DHASCO-B