Growth and Safety of a Low Lactose Milk-Based Infant Formula
An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
1 other identifier
interventional
85
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 15, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMay 15, 2013
May 1, 2013
1.2 years
December 15, 2011
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
16 weeks
Secondary Outcomes (3)
Length gain
16 weeks
Occipital Head Circumference
16 weeks
Acceptability and Tolerability
16 weeks
Study Arms (1)
Low Lactose Infant Formula
OTHERInterventions
Eligibility Criteria
You may qualify if:
- healthy term infants
- birth weight 2500 - 4500 g
- singleton birth
- weeks gestation
You may not qualify if:
- clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
- receiving medications other than vitamins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Accelovance Melbourne Site
Melbourne, Florida, 23935, United States
ACC Pediatric Research
Haughton, Louisiana, 71037, United States
Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Research Across America
Dallas, Texas, 75234, United States
Jean Brown Research
Murray, Utah, 84107, United States
PI-Coor Research
Burke, Virginia, 22015-1635, United States
Study Officials
- STUDY DIRECTOR
Cynthia M Barber, PhD
Perrigo Nutritionals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2011
First Posted
December 22, 2011
Study Start
December 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 15, 2013
Record last verified: 2013-05