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OpenTrials
Completed

NCT Number: NCT02144402

Growth of Healthy Term Infants Fed Formula Containing DHA-B

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.

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Key information

Conditions

Growth Infant Development Tolerance

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Claude Ashley, MD, Dothan, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infant formula with DHASCO

Other

infant formula with DHASCO-B

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. length (cm)

    Time frame: through day of life 120

    Length in cm

  2. head circumference (cm)

    Time frame: through day of life 120

    head circumference (cm)

  3. 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

  4. Formula intake and tolerance

    Time frame: Day of life 30 and 120

    assessed by analyzing three-day dietary intake and tolerance forms

Other outcomes

  1. adverse events

    Time frame: through day of life 120

    AEs collected throughout the study

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

  • Accelovance

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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