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

This study has been completed.
Information provided by (Responsible Party):
Perrigo Nutritionals Identifier:
First received: December 15, 2011
Last updated: May 14, 2013
Last verified: May 2013
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Condition Intervention
Growth Healthy Term Infants Other: Low Lactose Infant Formula

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Perrigo Nutritionals:

Primary Outcome Measures:
  • Weight [ Time Frame: 16 weeks ]

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

Enrollment: 85
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Lactose Infant Formula Other: Low Lactose Infant Formula
Low Lactose Infant Formula

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Perrigo Nutritionals Identifier: NCT01497314     History of Changes
Other Study ID Numbers: PRG-VA-12-001
Study First Received: December 15, 2011
Last Updated: May 14, 2013

Keywords provided by Perrigo Nutritionals:
healthy term infants
infant formula processed this record on August 21, 2017