Completed

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

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What is being tested

Arachidonic acid (25 mg/100 kcal )

+ Arachidonic acid (34 mg/100 kcal)

+ Placebo

Dietary Supplement
Who is being recruted

+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: December 2009
See protocol details

Summary

Principal SponsorUniversity of Alberta
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleAssessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
NCT02092857
Principal SponsorUniversity of Alberta
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

89 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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.
8 exclusion criteria prevent from participating
corticosteroid use
red cell or plasma transfusions
IV lipid emulsions prior to study entry
major congenital malformations
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid

Group II

Active Comparator
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid

Group III

Placebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Alberta Hospital

Edmonton, CanadaOpen University of Alberta Hospital in Google Maps
CompletedOne Study Center