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Tolerance and Development of Healthy, Term Infants

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00465764
First received: April 23, 2007
Last updated: April 24, 2009
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Other: Alternate protein infant formula
Other: Standard infant formula
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Mean rank stool consistency at 14 days of age [ Time Frame: 14 days of age ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protein formula
Feed as per HCP direction
 Other: Alternate protein infant formula
Feed as per HCP directions
Active Comparator: Standard infant formula
Feed as per HCP instructions
 Other: Standard infant formula
Feed as per HCP directions

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465764

Locations
United States, Nebraska
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68505
United States, Texas
Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Marlene W Borschel, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00465764     History of Changes
Other Study ID Numbers: AK44
Study First Received: April 23, 2007
Last Updated: April 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Nutrition:
healthy infants

ClinicalTrials.gov processed this record on May 23, 2013