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Tolerance and Development of Healthy, Term Infants

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ClinicalTrials.gov Identifier: NCT00465764
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : April 27, 2009
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Healthy Other: Alternate protein infant formula Other: Standard infant formula Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas
Study Start Date : April 2007
Primary Completion Date : April 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean rank stool consistency at 14 days of age [ Time Frame: 14 days of age ]

Secondary Outcome Measures :
  1. Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465764

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
Study Chair: Marlene W Borschel, PhD Abbott Nutrition

Responsible Party: Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00465764     History of Changes
Other Study ID Numbers: AK44
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: June 2008

Keywords provided by Abbott Nutrition:
healthy infants