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

NCT ID: NCT02092857

Last Updated: 2014-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Focus: Nutritional Requirements for Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

34 mg/100 kcal arachidonic acid

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

Group Type ACTIVE_COMPARATOR

Arachidonic acid (34 mg/100 kcal)

Intervention Type DIETARY_SUPPLEMENT

25 mg/100 kcal arachidonic acid

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

Group Type ACTIVE_COMPARATOR

Arachidonic acid (25 mg/100 kcal )

Intervention Type DIETARY_SUPPLEMENT

Infant formula without arachidonic acid

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arachidonic acid (25 mg/100 kcal )

Intervention Type DIETARY_SUPPLEMENT

Arachidonic acid (34 mg/100 kcal)

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

14 Days

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mead Johnson Nutrition

INDUSTRY

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael T Clandinin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

230831

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00005583

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

DHA Supplementation for Lactating Mothers
NCT01732874 COMPLETED PHASE1/PHASE2