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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Abbott Nutrition

Additional 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
Study First Received: July 14, 2009
Last Updated: November 24, 2010
Health Authority: Brazil: Ethics Committee

ClinicalTrials.gov processed this record on September 18, 2014