Effects of Early Nutrition on Growth

March 27, 2017 updated by: Abbott Nutrition

Effects of Early Nutrient Intake on Growth and Body Composition

The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

649

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • MRC Childhood Nutrition Research Center, Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • good health
  • singleton birth with gestational age 37-42 weeks
  • infant's birth weight >or = to 2500 grams
  • exclusive breastfeeding or exclusively formula feeding
  • within a defined geographical boundary
  • mother has no problems communicating in English

Exclusion Criteria:

  • adverse maternal, fetal or infant medical history
  • congenital disease or malformation affecting growth or development
  • illness or social problems in mother or infant
  • temporary residents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Human Milk
ad lib
Other: Human Milk
ad lib
Active Comparator: Milk based standard infant formula
ad lib
Other: Milk based standard infant formula
ad lib
Experimental: Milk based investigational infant formula
ad lib
Other: Investigational infant formula
ad lib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 1- 365 days
1- 365 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal tolerance
Time Frame: 1-365 days
1-365 days
Infant Anthropometrics
Time Frame: 1 - 365 days; 24 months
1 - 365 days; 24 months

Other Outcome Measures

Outcome Measure
Time Frame
Vascular
Time Frame: at 24 months
at 24 months
Maternal Anthropometrics
Time Frame: at 24 months
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Collaborators

Institute of Child Health

Investigators

  • Study Chair: Barbara Marriage, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • AK65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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