Evaluation of Mineral Absorption in Infants Fed Infant Formula

March 4, 2009 updated by: Mead Johnson Nutrition
The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.

Study Type

Interventional

Enrollment (Anticipated)

44

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
        • Fomon Infant Nutrition Unit
    • 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
    • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, term infants

Exclusion Criteria:

  • Breast fed infants
  • Use of vitamin/mineral supplements
  • Currently on medication

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?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
cow-milk based infant formula
Procedure: Calcium absorption
formula with or without prebiotics
Experimental: 2
cow-milk based infant formula with prebiotics
Procedure: Calcium absorption
formula with or without prebiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Calcium absorption
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Vitamin D levels
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: James Heubi, M.D., Children's Hospital Medical Center, Cincinnati

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

September 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 5, 2009

Last Update Submitted That Met QC Criteria

March 4, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3374-1151

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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