Healthy Term Infants Fed Milk-Based Formulas
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2012
CompletedFirst Posted
Study publicly available on registry
June 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 15, 2013
February 1, 2013
1.4 years
June 10, 2012
February 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
calcium absorption
as measured in stool
8 days
Secondary Outcomes (4)
stool consistency
28 days
fat absorption
8 days
average number of stools per day
28 days
percent of feedings with spit up/vomit associated with feeding per day.
28 days
Study Arms (2)
Powdered milk-based formula, standard fat blend
ACTIVE COMPARATORPowder milk-based formula, alternate fat blend
EXPERIMENTALInterventions
formula to be consumed ad lib
formula to be consumed ad lib
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
University of Colorado Denver
Aurora, Colorado, 80045, United States
Study Officials
- STUDY CHAIR
John Lasekan, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2012
First Posted
June 13, 2012
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 15, 2013
Record last verified: 2013-02