Growth of Infants Fed an Elemental Medical Food

NCT ID: NCT01699386

Last Updated: 2012-10-03

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

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2000-12-31

Brief Summary

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Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Detailed Description

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Conditions

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Healthy Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Study Formula

protein hydrolysate formula

Group Type ACTIVE_COMPARATOR

Control Study Formula

Intervention Type OTHER

feed as lib

Experimental Study Formula

free-amino acid-based medical food

Group Type EXPERIMENTAL

Experimental Study Formula

Intervention Type OTHER

feed as lib

Interventions

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Control Study Formula

feed as lib

Intervention Type OTHER

Experimental Study Formula

feed as lib

Intervention Type OTHER

Other Intervention Names

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protein hydrolysate formula Nutramigen free-amino acid-based medical food EleCare

Eligibility Criteria

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Inclusion Criteria

* Singleton, healthy infant
* Gestational age of 37 to 42 weeks
* Birth weight of 2500 grams or greater
* Age between birth and 9 days of age
* Parents agree to not administer mineral or vitamin supplements during the study period
* Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria

* Maternal, fetal or perinatal history which may have adverse effects on growth
* Multiple birth
Maximum Eligible Age

9 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marlene W Borschel, PhD, RD

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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T&W Research

Little Rock, Arkansas, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

Reference Type DERIVED
PMID: 33006765 (View on PubMed)

Other Identifiers

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AH73

Identifier Type: -

Identifier Source: org_study_id