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Effects of Early Nutrition on Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01300000
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Infant Newborn Other: Human Milk Other: Investigational infant formula Other: Milk based standard infant formula

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 649 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Early Nutrient Intake on Growth and Body Composition
Actual Study Start Date : March 2010
Primary Completion Date : September 2014
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Human Milk
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Other: Human Milk
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Active Comparator: Milk based standard infant formula
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Other: Milk based standard infant formula
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Experimental: Milk based investigational infant formula
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Other: Investigational infant formula
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Outcome Measures

Primary Outcome Measures :
  1. Weight gain [ Time Frame: 1- 365 days ]

Secondary Outcome Measures :
  1. Gastrointestinal tolerance [ Time Frame: 1-365 days ]
  2. Infant Anthropometrics [ Time Frame: 1 - 365 days; 24 months ]

Other Outcome Measures:
  1. Vascular [ Time Frame: at 24 months ]
  2. Maternal Anthropometrics [ Time Frame: at 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300000


Locations
United Kingdom
MRC Childhood Nutrition Research Center, Institute of Child Health
London, United Kingdom
Sponsors and Collaborators
Abbott Nutrition
Institute of Child Health
Investigators
Study Chair: Barbara Marriage, PhD Abbott Nutrition
More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01300000     History of Changes
Other Study ID Numbers: AK65
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided