LCPUFA Supplementation: A Multi-Modality Imaging Study

NCT ID: NCT02076048

Last Updated: 2015-10-08

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

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to take images of the brain in order to see if long-chain polyunsaturated fatty acid (LCPUFA) exposure during infancy influences brain structure and function in middle childhood.

Detailed Description

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LCPUFAs are essential fatty acids that are found in all cells of the body, particularly in the brain, retina and other nervous tissue. LCPUFAs are found naturally in seeds, nuts, fish and human breast milk. The body can also make LCPUFAs from shorter-chain fatty acid precursors.

The researchers in the study have previously found that LCPUFA supplementation during infancy has a beneficial effect on vision and development in the early years of life. However, researchers feel there is a growing need to better understand if there are structural and/or functional changes in the brain that explain these benefits. It is also important to understand if changes in development are still present later in childhood.

Conditions

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Child Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previous LCPUFA Supplementation

Children between the ages of 7 and 10 that were previously enrolled in a study of supplemented LCPUFA formula.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Parents consent for children and children have the ability to assent
* Participation as an infant in the original study

Exclusion Criteria

* Those with orthodontic braces or extensive dental work that would make them unable to have an MRI
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mead Johnson Nutrition

INDUSTRY

Sponsor Role collaborator

Kathleen Gustafson, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Gustafson, Ph.D.

Research Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kathleen M Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Lepping RJ, Honea RA, Martin LE, Liao K, Choi IY, Lee P, Papa VB, Brooks WM, Shaddy DJ, Carlson SE, Colombo J, Gustafson KM. Long-chain polyunsaturated fatty acid supplementation in the first year of life affects brain function, structure, and metabolism at age nine years. Dev Psychobiol. 2019 Jan;61(1):5-16. doi: 10.1002/dev.21780. Epub 2018 Oct 11.

Reference Type DERIVED
PMID: 30311214 (View on PubMed)

Other Identifiers

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LCPUFA Supplementation

Identifier Type: -

Identifier Source: org_study_id

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