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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PBM Products
ClinicalTrials.gov Identifier:
NCT01497314
First received: December 15, 2011
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 PBM Products:

Primary Outcome Measures:
  • Weight [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length gain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Occipital Head Circumference [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Acceptability and Tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01497314

Locations
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
PBM Products
Investigators
Study Director: Cynthia M Barber, PhD PBM Products
  More Information

No publications provided

Responsible Party: PBM Products
ClinicalTrials.gov Identifier: NCT01497314     History of Changes
Other Study ID Numbers: PRG-VA-12-001
Study First Received: December 15, 2011
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by PBM Products:
healthy term infants
growth
infant formula

ClinicalTrials.gov processed this record on July 08, 2014