Status:
COMPLETED
Growth and Safety of a Low Lactose Milk-Based Infant Formula
Lead Sponsor:
Perrigo Nutritionals
Conditions:
Growth
Healthy Term Infants
Eligibility:
All Genders
Up to 14 years
Phase:
NA
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.
Detailed Description
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.
Eligibility Criteria
Inclusion
- healthy term infants
- birth weight 2500 - 4500 g
- singleton birth
- 37 - 42 weeks gestation
Exclusion
- clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
- receiving medications other than vitamins
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01497314
Start Date
December 1 2011
End Date
March 1 2013
Last Update
May 15 2013
Active Locations (6)
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1
Accelovance Melbourne Site
Melbourne, Florida, United States, 23935
2
ACC Pediatric Research
Haughton, Louisiana, United States, 71037
3
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
4
Research Across America
Dallas, Texas, United States, 75234