We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Term Infants Fed Milk-Based Formulas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617889
First Posted: June 13, 2012
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abbott Nutrition
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • calcium absorption [ Time Frame: 8 days ]
    as measured in stool


Secondary Outcome Measures:
  • stool consistency [ Time Frame: 28 days ]
    measured on 5 point scale

  • fat absorption [ Time Frame: 8 days ]
    as measured in stool

  • average number of stools per day [ Time Frame: 28 days ]
  • percent of feedings with spit up/vomit associated with feeding per day. [ Time Frame: 28 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   53 Days to 115 Days   (Child)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01617889     History of Changes
Other Study ID Numbers: AK88
First Submitted: June 10, 2012
First Posted: June 13, 2012
Last Update Posted: February 15, 2013
Last Verified: February 2013