Evaluation of Mineral Absorption in Infants Fed Infant Formula

NCT ID: NCT00366873

Last Updated: 2009-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

cow-milk based infant formula

Group Type ACTIVE_COMPARATOR

Calcium absorption

Intervention Type PROCEDURE

formula with or without prebiotics

2

cow-milk based infant formula with prebiotics

Group Type EXPERIMENTAL

Calcium absorption

Intervention Type PROCEDURE

formula with or without prebiotics

Interventions

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Calcium absorption

formula with or without prebiotics

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy, term infants

Exclusion Criteria

* Breast fed infants
* Use of vitamin/mineral supplements
* Currently on medication
Minimum Eligible Age

56 Days

Maximum Eligible Age

70 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Mead Johnson

Principal Investigators

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James Heubi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Fomon Infant Nutrition Unit

Coralville, Iowa, United States

Site Status

Pediatric Clinical Trials Unit

Louisville, Kentucky, United States

Site Status

The Center for Human Nutrition

Omaha, Nebraska, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

Children's Research and Nutrition Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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3374-1151

Identifier Type: -

Identifier Source: org_study_id

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