Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

March 10, 2014 updated by: Mead Johnson Nutrition
To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

86

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2P5
        • Alberta Institute for Human Nutrition, University of Alberta

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 week to 3 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants 12-25 days of age

Description

Inclusion Criteria:

  • Singleton birth
  • 12-25 days of age
  • Gestational age of 37-42 weeks
  • Solely formula fed for at least 24 hours prior to randomization
  • Birth weight 2500 g - 4000 g

Exclusion Criteria:

  • Serious concurrent illness or congenital malformation
  • Systemic or congenital infection
  • Immunocompromised
  • History of intolerance or allergy to cow milk
  • Maternal autoimmune disorder
  • Participation in another clinical study

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

Cohorts and Interventions

Group / Cohort
Control
Marketed cow milk-based infant formula containing DHA and ARA
Investigational 1
Cow milk-based infant formula with differing level of ARA from Control formula
Investigational 2
Cow milk-based infant formula with a differing level of ARA from Control

Collaborators and Investigators

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

Sponsor

Mead Johnson Nutrition

Collaborators

University of Alberta

Investigators

  • Principal Investigator: Tom Clandinin, Ph.D., University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 6000

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.

Clinical Trials on Levels of Fatty Acids in the Blood Cells of Infants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe