NCT02069522

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 18, 2014

Last Update Submit

March 20, 2015

Conditions

Infants

Outcome Measures

Primary Outcomes (1)

  • Carotenoid Concentration

    Plasma sample

    Change from Baseline to end of Study Period A (~21 Days)

Secondary Outcomes (1)

  • Carotenoid Concentration

    Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)

Study Arms (2)

Standard Milk-based Formula Containing Carotenoid

ACTIVE COMPARATOR

milk-based ready to feed infant formula

Other: Standard Milk-based Formula Containing Carotenoid

Investigational Milk-based Formula Containing Carotenoid

EXPERIMENTAL

investigational milk-based ready to feed infant formula

Other: Investigational Milk-based Formula Containing Carotenoid

Interventions

Standard Milk-based Formula Containing CarotenoidOTHER

Fed ad libitum

Standard Milk-based Formula Containing Carotenoid
Investigational Milk-based Formula Containing CarotenoidOTHER

Fed ad libitum

Investigational Milk-based Formula Containing Carotenoid

Eligibility Criteria

Age14 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tuscon Medical Center

Tuscon, Arizona, 85712, United States

Location

Northpoint Pediatrics

Indianapolis, Indiana, 46256, United States

Location

Midwest Children's Health Research Institute

Lincoln, Nebraska, 68505, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Institute of Clinical Research

Mayfield Heights, Ohio, 44143, United States

Location

Study Officials

  • John B Lasekan, PhD, CCRP

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 24, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

US(6)