Effects of Early Nutrition on Growth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Abbott Nutrition.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Institute of Child Health
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01300000
First received: February 17, 2011
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Infant Newborn
Other: Human Milk
Other: Investigational infant formula
Other: Milk based standard infant formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Early Nutrient Intake on Growth and Body Composition

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 1- 365 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gastrointestinal tolerance [ Time Frame: 1-365 days ] [ Designated as safety issue: No ]
  • Infant Anthropometrics [ Time Frame: 1 - 365 days; 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Vascular [ Time Frame: at 24 months ] [ Designated as safety issue: No ]
  • Maternal Anthropometrics [ Time Frame: at 24 months ] [ Designated as safety issue: No ]

Enrollment: 649
Study Start Date: March 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01300000     History of Changes
Other Study ID Numbers: AK65
Study First Received: February 17, 2011
Last Updated: September 20, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on October 19, 2014