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

NCT02092857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2014-04-25

Study results available
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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.

Conditions

  • Focus: Nutritional Requirements for Infants

Interventions

DIETARY_SUPPLEMENT

Arachidonic acid (25 mg/100 kcal )

DIETARY_SUPPLEMENT

Arachidonic acid (34 mg/100 kcal)

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • University of Alberta

    lead OTHER

Principal Investigators

  • Michael T Clandinin, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-11-30
Completion
2014-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092857 on ClinicalTrials.gov