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Trial record 1 of 1 for:    NCT00941564
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Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

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ClinicalTrials.gov Identifier: NCT00941564
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : November 25, 2010
Sponsor:
Information provided by:
Abbott Nutrition

Tracking Information
First Submitted Date  ICMJE July 14, 2009
First Posted Date  ICMJE July 17, 2009
Last Update Posted Date November 25, 2010
Study Start Date  ICMJE March 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
Calcium absorption [ Time Frame: 18 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2009)
Calcium retention, fat absorption, tolerance [ Time Frame: 18 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 Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
Official Title  ICMJE "Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
Brief Summary The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infant
Intervention  ICMJE
  • Other: Infant Formula milk based
    Consume ad lib
  • Other: Infant formula milk based
    consume ad lib
Study Arms  ICMJE
  • Experimental: Commercially available infant formula A
    Varying fat blend from comparator product
    Intervention: Other: Infant Formula milk based
  • Active Comparator: Commercially available infant formula B
    Intervention: Other: Infant formula milk based
Publications *

*   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: July 29, 2010)
33
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2009)
40
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
  • Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.

Exclusion Criteria:

  • Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics 3 days prior to enrollment.
  • Infant has received probiotics-containing products 3 days prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 84 Days to 159 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941564
Other Study ID Numbers  ICMJE AK76
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bobbie Swearengin, Abbott Nutrition
Study Sponsor  ICMJE Abbott Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Lasekan, PhD Abbott Nutrition
PRS Account Abbott Nutrition
Verification Date November 2010

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