NCT01137877

Brief Summary

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
399

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

20 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

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

June 3, 2010

Last Update Submit

November 24, 2010

Conditions

Healthy Term Infants

Outcome Measures

Primary Outcomes (1)

  • weight gain

    14 to 119 days of age

Secondary Outcomes (2)

  • GI tolerance

    14 to 119 days of age

  • anthropometrics

    14 to 119 days of age

Study Arms (4)

Infant Formula #1

ACTIVE COMPARATOR

Milk-based Infant Formula Powder

Other: Milk based infant formula powder

Investigational Infant Formula #1

EXPERIMENTAL

Investigational Milk-based Infant Formula Powder

Other: Investigational Infant Formula #1

Investigational Infant Formula #2

EXPERIMENTAL

Investigational Milk based infant formula powder

Other: Investigational Infant Formula #2

Human Milk

ACTIVE COMPARATOR

Reference group

Other: Human Milk

Interventions

Milk based infant formula powderOTHER

milk based infant formula ad lib

Infant Formula #1
Investigational Infant Formula #1OTHER

Milk based infant formula ad lib

Investigational Infant Formula #1
Investigational Infant Formula #2OTHER

Milk based infant formula powder ad lib

Investigational Infant Formula #2
Human MilkOTHER

Human milk ad lib

Human Milk

Eligibility Criteria

Age1 Day - 11 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • in good health
  • singleton full term birth
  • Birth weight \> 2490 g.
  • Infant is between 0 and 11 days of age
  • Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
  • If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
  • not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Arkansas Children's Hospital Research

Little Rock, Arkansas, 72202, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

Norwich Pediatric Group

Norwich, Connecticut, 06360, United States

Location

All Women's Healthcare of West Broward, Inc

Plantation, Florida, 33324, United States

Location

SCORE Physician Alliance LLC

St. Petersburg, Florida, 33710, United States

Location

USF College of Medicine, USF Health, Department of Pediatrics

Tampa, Florida, 33606, United States

Location

Northpoint Pediatrics

Indianapolis, Indiana, 46038, United States

Location

University of Louisville Department of Pediatrics

Louisville, Kentucky, 40202, United States

Location

New England Center for Clinical Research, Inc

Fall River, Massachusetts, 02720, United States

Location

Wayzata Children's Clinic Ridgeview Research

Chaska, Minnesota, 55318, United States

Location

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, 68504, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89123, United States

Location

Cary Pediatric Center

Cary, North Carolina, 27518, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45406, United States

Location

Ohio Pediatric Research Association, Inc

Huber Heights, Ohio, 45424, United States

Location

Parma Pediatrics

Parma, Ohio, 44129, United States

Location

Comprehensive Pediatrics, Inc

Westlake, Ohio, 44145, United States

Location

Sanford Clinic Family Medicine 34th and Kiwanis

Sioux Falls, South Dakota, 57105, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Rockwood Clinic North Pediatrics

Spokane, Washington, 99218, United States

Location

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Timberly Williams, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2010

First Posted

June 7, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 25, 2010

Record last verified: 2010-11

Locations

US(20)