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Evaluation of Mineral Absorption in Infants Fed Infant Formula

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01177917
First received: August 6, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

This clinical trial will help determine if prebiotics can increase mineral absorption in babies


Condition Intervention
Mineral Absorption in the Urine
 Other: Infant Formula

Study Type: Interventional

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • To evaluate the amount of minerals in the urine

Secondary Outcome Measures:
  • Compare the amount of vitamins and minerals in the blood

Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cow milk-based infant formula with prebiotic blend Other: Infant Formula
Placebo Comparator: Marketed Cow milk-based infant formula Other: Infant Formula

  Eligibility

Ages Eligible for Study:   56 Days to 70 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Singleton
  • Term infant
  • Birth weight of 2500 g or more
  • 56-70 days of age
  • Signed informed consent
  • Consuming a cow's milk-based infant formula for at least 24 hours.

Exclusion Criteria:

  • History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
  • Use of multiple vitamin and mineral supplements prior to enrollment.
  • Evidence of formula intolerance or poor intake at time of randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177917

Locations
United States, Iowa
Children's Hospital of Iowa
Coralville, Iowa, United States, 52241
United States, Kentucky
Pediatric Clinical Trials Unit
Louisville, Kentucky, United States, 40202
United States, Nebraska
The Center for Human Nutrition
Omaha, Nebraska, United States, 68105
United States, Ohio
Cincinnati Children's Hospital Medical Center Clinical Trials Office
Cincinnati, Ohio, United States, 45229
United States, Texas
Children's Research and Nutrition Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mead Johnson Nutrition
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01177917     History of Changes
Other Study ID Numbers: 3371-4
Study First Received: August 6, 2010
Last Updated: August 6, 2010
Health Authority: United States: Institutional Review Board for Baylor College of Medicine and Affiliated Hospitals

ClinicalTrials.gov processed this record on May 23, 2013