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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:
ClinicalTrials.gov Identifier:
NCT00941564
First Posted: July 17, 2009
Last Update Posted: November 25, 2010
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.
Information provided by:
Abbott Nutrition
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Calcium absorption [ Time Frame: 18 days ]

Secondary Outcome Measures:
  • Calcium retention, fat absorption, tolerance [ Time Frame: 18 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   84 Days to 159 Days   (Child)
Sexes Eligible for Study:   All
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
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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bobbie Swearengin, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT00941564     History of Changes
Other Study ID Numbers: AK76
First Submitted: July 14, 2009
First Posted: July 17, 2009
Last Update Posted: November 25, 2010
Last Verified: November 2010