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Healthy Term Infants Fed Milk-Based Formulas

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

Tracking Information
First Submitted Date  ICMJE June 10, 2012
First Posted Date  ICMJE June 13, 2012
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE March 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
calcium absorption [ Time Frame: 8 days ]
as measured in stool
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01617889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Term Infants Fed Milk-Based Formulas
Official Title  ICMJE Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Term Infant
Intervention  ICMJE
  • Other: Experimental powdered milk-based infant formula with an alternate fat blend
    formula to be consumed ad lib
  • Other: A powdered milk-based infant formula, standard fat blend
    formula to be consumed ad lib
Study Arms  ICMJE
  • Active Comparator: Powdered milk-based formula, standard fat blend
    Intervention: Other: A powdered milk-based infant formula, standard fat blend
  • Experimental: Powder milk-based formula, alternate fat blend
    Intervention: Other: Experimental powdered milk-based infant formula with an alternate fat blend
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2013)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
24
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 53 Days to 115 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01617889
Other Study ID Numbers  ICMJE AK88
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Nutrition
Study Sponsor  ICMJE Abbott Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: John Lasekan, PhD Abbott Nutrition
PRS Account Abbott Nutrition
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP