Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants

March 24, 2014 updated by: University of Alberta
The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 1

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, T6G 2B7
        • University of Alberta Hospital

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 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • healthy term infants
  • birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)
  • receiving >80% for their intake by mouth from commercial infant formula
  • low-risk for allergy based on a negative family history.

Exclusion criteria:

  • corticosteroid use
  • red cell or plasma transfusions
  • IV lipid emulsions prior to study entry
  • major congenital malformations
  • systemic or congenital infection
  • significant neonatal morbidity
  • maternal autoimmune disorders
  • acute illness precluding oral feedings or conditions requiring feedings other than standard formula

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 34 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
Dietary supplement: Arachidonic acid (34 mg/100 kcal)
Active Comparator: 25 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
Dietary supplement: Arachidonic acid (25 mg/100 kcal )
Placebo Comparator: Infant formula without arachidonic acid
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Dietary supplement: Placebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Antigen-presenting B Cells
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

University of Alberta

Collaborators

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Michael T Clandinin, PhD, University of Alberta

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

December 1, 2009

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00005583
  • 230831 (Other Grant/Funding Number: CIHR)

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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