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Healthy Term Infants Fed Milk-Based Formulas

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ClinicalTrials.gov Identifier: NCT01617889
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : March 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: June 13, 2012    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013