Evaluation of Mineral Absorption in Infants Fed Infant Formula

August 6, 2010 updated by: Mead Johnson Nutrition
This clinical trial will help determine if prebiotics can increase mineral absorption in babies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the amount of minerals in the urine

Secondary Outcome Measures

Outcome Measure
Compare the amount of vitamins and minerals in the blood

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

August 9, 2010

Last Update Submitted That Met QC Criteria

August 6, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 3371-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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