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Evaluation of Mineral Absorption in Infants Fed Infant Formula

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ClinicalTrials.gov Identifier: NCT01177917
Recruitment Status : Completed
First Posted : August 9, 2010
Last Update Posted : August 9, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
This clinical trial will help determine if prebiotics can increase mineral absorption in babies

Condition or disease Intervention/treatment
Mineral Absorption in the Urine Other: Infant Formula

Study Design

Study Type : Interventional  (Clinical Trial)
Study Start Date : August 2006
Primary Completion Date : September 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cow milk-based infant formula with prebiotic blend Other: Infant Formula
Placebo Comparator: Marketed Cow milk-based infant formula Other: Infant Formula


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   56 Days to 70 Days   (Child)
Sexes Eligible for Study:   All
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

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): 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

ClinicalTrials.gov Identifier: NCT01177917     History of Changes
Other Study ID Numbers: 3371-4
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010