Healthy Term Infants Fed Milk-Based Formulas

Infants Clinical Trial

Official title:

Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02069522
• Other study ID #: AL13
• Status: Terminated
• Phase: N/A
• First received: February 18, 2014
• Last updated: March 20, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Infant is in good health

• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks

• Infant's birth weight was > 2490 g (~5 lbs 8 oz)

• Infant is between 14 and 28 days of age

• Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study

• Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.

• Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infants

Intervention

Other:
• Standard Milk-based Formula Containing Carotenoid
Fed ad libitum
• Investigational Milk-based Formula Containing Carotenoid
Fed ad libitum

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Dayton Clinical Research	Dayton	Ohio
United States	Northpoint Pediatrics	Indianapolis	Indiana
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	Tuscon Medical Center	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotenoid Concentration	Plasma sample	Change from Baseline to end of Study Period A (~21 Days)	No
Secondary	Carotenoid Concentration	Plasma sample	Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)	No