Growth and Safety of a Low Lactose Milk-Based Infant Formula

NCT ID: NCT01497314

Last Updated: 2013-05-15

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

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Detailed Description

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Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Conditions

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Growth Healthy Term Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Low Lactose Infant Formula

Group Type OTHER

Low Lactose Infant Formula

Intervention Type OTHER

Low Lactose Infant Formula

Interventions

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Low Lactose Infant Formula

Low Lactose Infant Formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy term infants
* birth weight 2500 - 4500 g
* singleton birth
* 37 - 42 weeks gestation

Exclusion Criteria

* clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
* receiving medications other than vitamins
Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Perrigo Nutritionals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia M Barber, PhD

Role: STUDY_DIRECTOR

Perrigo Nutritionals

Locations

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Accelovance Melbourne Site

Melbourne, Florida, United States

Site Status

ACC Pediatric Research

Haughton, Louisiana, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

Jean Brown Research

Murray, Utah, United States

Site Status

PI-Coor Research

Burke, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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PRG-VA-12-001

Identifier Type: -

Identifier Source: org_study_id

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