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NCT01497314 Clinical Trial

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

Growth Clinical Trial

Official title:
An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01497314
Other study ID # PRG-VA-12-001
Secondary ID
Status Completed
Phase N/A
First received December 15, 2011
Last updated May 14, 2013
Start date December 2011
Est. completion date March 2013

Study information
Verified date May 2013
Source Perrigo Nutritionals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 14 Days
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Low Lactose Infant Formula
Low Lactose Infant Formula

Locations
Country Name City State
United States PI-Coor Research Burke Virginia
United States Research Across America Dallas Texas
United States ACC Pediatric Research Haughton Louisiana
United States Center for Pharmaceutical Research Kansas City Missouri
United States Accelovance Melbourne Site Melbourne Florida
United States Jean Brown Research Murray Utah

Sponsors (1)
Lead Sponsor Collaborator
Perrigo Nutritionals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight 16 weeks No
Secondary Length gain 16 weeks No
Secondary Occipital Head Circumference 16 weeks No
Secondary Acceptability and Tolerability Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications 16 weeks No
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