Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014