Evaluation of Mineral Absorption in Infants Fed Infant Formula

NCT ID: NCT01177917

Last Updated: 2010-08-09

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

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

Brief Summary

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This clinical trial will help determine if prebiotics can increase mineral absorption in babies

Detailed Description

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Conditions

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Mineral Absorption in the Urine

Study Groups

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Cow milk-based infant formula with prebiotic blend

Group Type EXPERIMENTAL

Infant Formula

Intervention Type OTHER

Marketed Cow milk-based infant formula

Group Type PLACEBO_COMPARATOR

Infant Formula

Intervention Type OTHER

Interventions

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Infant Formula

Intervention Type OTHER

Eligibility Criteria

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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
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

Locations

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Children's Hospital of Iowa

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 Medical Center Clinical Trials Office

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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3371-4

Identifier Type: -

Identifier Source: org_study_id

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