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Evaluation of Mineral Absorption in Infants Fed Infant Formula

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177917
First Posted: August 9, 2010
Last Update Posted: August 9, 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:
Mead Johnson Nutrition
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: August 6, 2010
First Posted: August 9, 2010
Last Update Posted: August 9, 2010
Last Verified: August 2010