Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

Tolerance and Development of Healthy, Term Infants

Sponsors

Lead sponsor: Abbott Nutrition

Source Abbott Nutrition
Brief Summary

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Overall Status Completed
Start Date April 2007
Completion Date June 2008
Primary Completion Date April 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean rank stool consistency at 14 days of age 14 days of age
Secondary Outcome
Measure Time Frame
Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding 14 days
Enrollment 115
Condition
Intervention

Intervention type: Other

Intervention name: Alternate protein infant formula

Description: Feed as per HCP directions

Arm group label: Protein formula

Intervention type: Other

Intervention name: Standard infant formula

Description: Feed as per HCP directions

Arm group label: Standard infant formula

Eligibility

Criteria:

Inclusion Criteria:

- Healthy term infants;

- Age 0-8 days of age;

- Exclusively formula fed;

- No use of vitamin/mineral supplements.

Exclusion Criteria:

- Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Gender: All

Minimum age: N/A

Maximum age: 8 Days

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Marlene W Borschel, PhD Study Chair Abbott Nutrition
Location
facility
Midwest Children's Health Research Institute | Lincoln, Nebraska, 68505, United States
Children's Nutrition Research Center, Baylor College of Medicine | Houston, Texas, 77030, United States
Location Countries

United States

Verification Date

June 2008

Responsible Party

Name title: Bobbie Swearengin, Director Clinical Research Operations

Organization: Abbott Nutrition

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Protein formula

Arm group type: Experimental

Description: Feed as per HCP direction

Arm group label: Standard infant formula

Arm group type: Active Comparator

Description: Feed as per HCP instructions

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov