Growth and Safety of a Low Lactose Milk-Based Infant Formula
Not Applicable
Completed
- Conditions
- GrowthHealthy Term Infants
- Interventions
- Other: Low Lactose Infant Formula
- Registration Number
- NCT01497314
- Lead Sponsor
- 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.
- Detailed Description
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Low Lactose Infant Formula Low Lactose Infant Formula -
- Primary Outcome Measures
Name Time Method Weight 16 weeks
- Secondary Outcome Measures
Name Time Method Length gain 16 weeks Occipital Head Circumference 16 weeks Acceptability and Tolerability 16 weeks Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications
Trial Locations
- Locations (6)
ACC Pediatric Research
🇺🇸Haughton, Louisiana, United States
Accelovance Melbourne Site
🇺🇸Melbourne, Florida, United States
Jean Brown Research
🇺🇸Murray, Utah, United States
Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Research Across America
🇺🇸Dallas, Texas, United States
PI-Coor Research
🇺🇸Burke, Virginia, United States