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

University of Alberta

Status and phase: Completed; Phase 1

Conditions: Focus: Nutritional Requirements for Infants

Treatments: Dietary Supplement: Arachidonic acid (25 mg/100 kcal ); Dietary Supplement: Arachidonic acid (34 mg/100 kcal); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02092857

230831 (Other Grant/Funding Number)

Pro00005583

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 14 to 21 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 3 patient groups, including a placebo group

34 mg/100 kcal arachidonic acid

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Arachidonic acid (34 mg/100 kcal)

25 mg/100 kcal arachidonic acid

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Arachidonic acid (25 mg/100 kcal )

Infant formula without arachidonic acid

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo