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

Study Overview
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Brief Summary
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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 Title
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Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants

Conditions
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Focus: Nutritional Requirements for Infants

Intervention / Treatment
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* Dietary Supplement: Arachidonic acid (25 mg/100 kcal )
* Dietary Supplement: Arachidonic acid (34 mg/100 kcal)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Days
Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrient, nutrition, arachidonic acid, essential fatty acids