Skip to main content
OpenTrials
Completed

NCT Number: NCT02092857

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Focus: Nutritional Requirements for Infants

Age range

14 day–21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arachidonic acid (25 mg/100 kcal )

Dietary Supplement

Arachidonic acid (34 mg/100 kcal)

Dietary Supplement

Placebo

Dietary Supplement

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

Primary outcomes

  1. Number of Antigen-presenting B Cells

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.