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Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00941564
First received: July 14, 2009
Last updated: November 24, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Infant
 Other: Infant Formula milk based
Other: Infant formula milk based
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Calcium absorption [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium retention, fat absorption, tolerance [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Commercially available infant formula A
Varying fat blend from comparator product
 Other: Infant Formula milk based
Consume ad lib
Active Comparator: Commercially available infant formula B Other: Infant formula milk based
consume ad lib

  Eligibility

Ages Eligible for Study:   84 Days to 159 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941564

Locations
Brazil
Department of Pediatrics, Federal University of Bahia
Salvador, Bahia, Brazil
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Director: John Lasekan, PhD Abbott Nutrition
  More Information

No publications provided

Responsible Party: Bobbie Swearengin, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00941564     History of Changes
Other Study ID Numbers: AK76
Study First Received: July 14, 2009
Last Updated: November 24, 2010
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013