Healthy Term Infants Fed Milk-Based Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01617889
First received: June 10, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.


Condition Intervention Phase
Healthy Term Infant
Other: Experimental powdered milk-based infant formula with an alternate fat blend
Other: A powdered milk-based infant formula, standard fat blend
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • calcium absorption [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    as measured in stool


Secondary Outcome Measures:
  • stool consistency [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    measured on 5 point scale

  • fat absorption [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    as measured in stool

  • average number of stools per day [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • percent of feedings with spit up/vomit associated with feeding per day. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Powdered milk-based formula, standard fat blend Other: A powdered milk-based infant formula, standard fat blend
formula to be consumed ad lib
Experimental: Powder milk-based formula, alternate fat blend Other: Experimental powdered milk-based infant formula with an alternate fat blend
formula to be consumed ad lib

  Eligibility

Ages Eligible for Study:   53 Days to 115 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infant is judged to be in good health.
  • Infant is singleton from a full term birth
  • Infant's birth weight was > 2490 g.
  • Infant is between 53 and 115 days of age
  • Infant is on infant formula and tolerating infant formula feedings
  • Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
  • Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617889

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: John Lasekan, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01617889     History of Changes
Other Study ID Numbers: AK88
Study First Received: June 10, 2012
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014