Assessment of Fatty Acids in Infants' Blood Cells When Consuming Infant Formula Containing Long-Chain Polyunsaturated Fatty Acids

NCT ID: NCT01058187

Last Updated: 2014-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-07-31

Brief Summary

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To compare amounts of DHA, ARA, and other fatty acids in the blood cells of infants consuming infant formulas containing differing levels of fatty acids

Detailed Description

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Conditions

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Levels of Fatty Acids in the Blood Cells of Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Marketed cow milk-based infant formula containing DHA and ARA

No interventions assigned to this group

Investigational 1

Cow milk-based infant formula with differing level of ARA from Control formula

No interventions assigned to this group

Investigational 2

Cow milk-based infant formula with a differing level of ARA from Control

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Singleton birth
* 12-25 days of age
* Gestational age of 37-42 weeks
* Solely formula fed for at least 24 hours prior to randomization
* Birth weight 2500 g - 4000 g

Exclusion Criteria

* Serious concurrent illness or congenital malformation
* Systemic or congenital infection
* Immunocompromised
* History of intolerance or allergy to cow milk
* Maternal autoimmune disorder
* Participation in another clinical study
Minimum Eligible Age

12 Days

Maximum Eligible Age

25 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

Mead Johnson Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Mead Johnson Nutrition

Principal Investigators

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Tom Clandinin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Alberta Institute for Human Nutrition, University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Miklavcic JJ, Larsen BM, Mazurak VC, Scalabrin DM, MacDonald IM, Shoemaker GK, Casey L, Van Aerde JE, Clandinin MT. Reduction of Arachidonate Is Associated With Increase in B-Cell Activation Marker in Infants: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):446-453. doi: 10.1097/MPG.0000000000001283.

Reference Type DERIVED
PMID: 27276431 (View on PubMed)

Other Identifiers

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6000

Identifier Type: -

Identifier Source: org_study_id

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