Skip to main content
OpenTrials
Completed

NCT Number: NCT00465764

Tolerance and Development of Healthy, Term Infants

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

1 day–8 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Midwest Children's Health Research Institute, Lincoln, Nebraska, 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

  • Healthy term infants;
  • Age 0-8 days of age;
  • Exclusively formula fed;
  • No use of vitamin/mineral supplements.

Exclusion criteria

  • Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Treatment and study plan

Alternate protein infant formula

Other

Feed as per HCP directions

Standard Infant Formula

Other

Feed as per HCP directions

Primary outcomes

  1. Mean rank stool consistency at 14 days of age

    Time frame: 14 days of age

Secondary outcomes

  1. Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 25, 2007
Registry last updated
Apr 27, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.