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

May 14, 2013 updated by: Perrigo Nutritionals

An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

85

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
    • Florida
      • Melbourne, Florida, United States, 23935
        • Accelovance Melbourne Site
    • Louisiana
      • Haughton, Louisiana, United States, 71037
        • ACC Pediatric Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center For Pharmaceutical Research
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
    • Utah
      • Murray, Utah, United States, 84107
        • Jean Brown Research
    • Virginia
      • Burke, Virginia, United States, 22015-1635
        • PI-Coor Research

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

No older than 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Lactose Infant Formula
Other: Low Lactose Infant Formula
Low Lactose Infant Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length gain
Time Frame: 16 weeks
16 weeks
Occipital Head Circumference
Time Frame: 16 weeks
16 weeks
Acceptability and Tolerability
Time Frame: 16 weeks
Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications
16 weeks

Collaborators and Investigators

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

Sponsor

Perrigo Nutritionals

Investigators

  • Study Director: Cynthia M Barber, PhD, Perrigo Nutritionals

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

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRG-VA-12-001

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.

Clinical Trials on Growth

Clinical Trials on Low Lactose Infant Formula

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe