LCPUFA Supplementation: A Multi-Modality Imaging Study
1 other identifier
observational
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 8, 2015
October 1, 2015
2.1 years
February 25, 2014
October 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Event-Related Field (ERF) Amplitude and Latency
We will use an MEG Event-Related Field (ERF) to study the development of children's cognitive capabilities. The waveform components associated with information processing and response inhibition will be measured in order to assess the developmental progress of LCPUFA effects with increasing age.
Within 1 year post enrollment
Regional gray and white matter brain volume
Structural brain imaging is widely used to measure gray and white matter maturation patterns in young children. We will use automated, sensitive, and validated methods to test whether LCPUFA supplementation positively impacts changes in the brain associated with higher functioning and intelligence.
Within 1 year post enrollment
Secondary Outcomes (1)
Identify structural and metabolic mediators
Within 1 year post enrollment
Study Arms (1)
Previous LCPUFA Supplementation
Children between the ages of 7 and 10 that were previously enrolled in a study of supplemented LCPUFA formula.
Eligibility Criteria
Subjects who were originally enrolled as infants will be invited to participate in the longitudinal follow up study.
You may qualify if:
- Parents consent for children and children have the ability to assent
- Participation as an infant in the original study
You may not qualify if:
- Those with orthodontic braces or extensive dental work that would make them unable to have an MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kathleen Gustafson, Ph.D.lead
- Mead Johnson Nutritioncollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
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.
PMID: 30311214DERIVED
Biospecimen
cheek swab
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Gustafson, PhD
University of Kansas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
February 25, 2014
First Posted
March 3, 2014
Study Start
July 1, 2013
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
October 8, 2015
Record last verified: 2015-10