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

Phase 1

Completed

• Conditions: Focus: Nutritional Requirements for Infants
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Arachidonic acid (34 mg/100 kcal); Dietary Supplement: Arachidonic acid (25 mg/100 kcal )

• Registration Number: NCT02092857
• Lead Sponsor: University of Alberta

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Results First Submitted: 2014-03-24
• Results First Submitted QC: 2014-03-24
• Last Update Submitted: 2014-03-24
• Results First Posted: 2014-04-25
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula without arachidonic acid	Placebo	10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
34 mg/100 kcal arachidonic acid	Arachidonic acid (34 mg/100 kcal)	10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
25 mg/100 kcal arachidonic acid	Arachidonic acid (25 mg/100 kcal )	10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid

Primary Outcome Measures

Name	Time	Method
Number of Antigen-presenting B Cells	10 weeks

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada