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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497314
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):
Perrigo Nutritionals

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

Condition or disease Intervention/treatment Phase
Growth Healthy Term Infants Other: Low Lactose Infant Formula Not Applicable

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  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
Study Start Date : December 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Low Lactose Infant Formula Other: Low Lactose Infant Formula
Low Lactose Infant Formula

Primary Outcome Measures :
  1. Weight [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Length gain [ Time Frame: 16 weeks ]
  2. Occipital Head Circumference [ Time Frame: 16 weeks ]
  3. Acceptability and Tolerability [ Time Frame: 16 weeks ]
    Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497314

United States, Florida
Accelovance Melbourne Site
Melbourne, Florida, United States, 23935
United States, Louisiana
ACC Pediatric Research
Haughton, Louisiana, United States, 71037
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
United States, Utah
Jean Brown Research
Murray, Utah, United States, 84107
United States, Virginia
PI-Coor Research
Burke, Virginia, United States, 22015-1635
Sponsors and Collaborators
Perrigo Nutritionals
Study Director: Cynthia M Barber, PhD Perrigo Nutritionals

Responsible Party: Perrigo Nutritionals Identifier: NCT01497314     History of Changes
Other Study ID Numbers: PRG-VA-12-001
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Perrigo Nutritionals:
healthy term infants
infant formula