Effects of Early Nutrition on Growth | Not Recruiting
Effects of Early Nutrition on Growt... | Not Recruiting
Effects of Early Nutrition on Growth

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Medical Conditions
  • Infant Newborn
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT01300000

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Other : Human Milk, Other : Investigational infant formula, Other : Milk based standard infant formula

Study Arm Groups : Human Milk, Milk based investigational infant formula, Milk based standard infant formula

Intervention Type
See Interventions above
Primary Outcome Measures
    Weight gain; 1- 365 days
Secondary Outcome Measures
    Gastrointestinal tolerance; 1-365 days; Infant Anthropometrics; 1 - 365 days; 24 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
N/A - 24 Hours
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Effects of Early Nutrient Intake on Growth and Body Composition
EudraCT Number
Not available for this trial
Funder(s)
  • Institute of Child Health
Other Study ID Numbers
AK65
Sponsor(s)
Abbott Nutrition
Key Dates

Recruitment Start Date

Mar 2010

Recruitment End Date

Sep 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

17 Feb 2011

Date updated in source

29 Sep 2015