Phase 1 N=89 Randomized Double-blind Basic Science

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

Focus: Nutritional Requirements for Infants

Bottom Line

View on ClinicalTrials.gov: NCT02092857 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Apr 2014

Primary outcome: Primary: Number of Antigen-presenting B Cells — 21.9; 22.8; 25.1 percentage of CD20+ B cells

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Arachidonic acid (25 mg/100 kcal ) (Dietary_supplement); Arachidonic acid (34 mg/100 kcal) (Dietary_supplement); Placebo (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Antigen-presenting B Cells	21.9; 22.8; 25.1	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02092857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.