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

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ClinicalTrials.gov Identifier: NCT02092857
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
Sponsor:
Collaborator:
Mead Johnson Nutrition
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Focus: Nutritional Requirements for Infants Dietary Supplement: Arachidonic acid (25 mg/100 kcal ) Dietary Supplement: Arachidonic acid (34 mg/100 kcal) Dietary Supplement: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Study Start Date : December 2009
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 34 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
Dietary Supplement: Arachidonic acid (34 mg/100 kcal)
Active Comparator: 25 mg/100 kcal arachidonic acid
10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
Dietary Supplement: Arachidonic acid (25 mg/100 kcal )
Placebo Comparator: Infant formula without arachidonic acid
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
Dietary Supplement: Placebo
10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).




Primary Outcome Measures :
  1. Number of Antigen-presenting B Cells [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092857


Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Mead Johnson Nutrition
Investigators
Principal Investigator: Michael T Clandinin, PhD University of Alberta

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02092857     History of Changes
Other Study ID Numbers: Pro00005583
230831 ( Other Grant/Funding Number: CIHR )
First Posted: March 20, 2014    Key Record Dates
Results First Posted: April 25, 2014
Last Update Posted: April 25, 2014
Last Verified: March 2014

Keywords provided by University of Alberta:
nutrient
nutrition
arachidonic acid
essential fatty acids