Child DevelopmentNCT02076048
LCPUFA Supplementation: A Multi-Modality Imaging Study
An observational study of Child Development, run by Kathleen Gustafson, Ph.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects who were originally enrolled as infants will be invited to participate in the longitudinal follow up study.
Who may be able to join
- Parents consent for children and children have the ability to assent
- Participation as an infant in the original study
Who cannot join
- Those with orthodontic braces or extensive dental work that would make them unable to have an MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the detailed description
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
- Child Development
- Keywords
- LCPUFA supplementation, Brain Imaging, MRI, MEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Previous LCPUFA Supplementation | Children between the ages of 7 and 10 that were previously enrolled in a study of supplemented LCPUFA formula. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 1 year post enrollment
Secondary outcomes (1)
Identify structural and metabolic mediators
In a single imaging session, we will measure metabolic biomarkers associated with cellular mechanisms such as bioenergetics, membrane status, and oxidative state, each of which have been implicated as associated with LCPUFA supplementation.
Measured: Within 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Gustafson, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Responsible party
- Sponsor-investigator, Kathleen Gustafson, Ph.D., University of Kansas Medical Center
- Investigators
- Kathleen M Gustafson, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076048
- Sponsor's protocol ID
- LCPUFA Supplementation
- Status last verified
- Oct 2015
- First submitted
- 25 Feb 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30311214
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCPUFA Supplementation: A Multi-Modality Imaging Study
- ClinicalTrials.gov ID
- NCT02076048
- Acronym / sponsor ID
- LCPUFA Supplementation
- Conditions
- Child Development
- Keywords
- LCPUFA supplementation, Brain Imaging, MRI, MEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kathleen Gustafson, Ph.D.University, hospital or other
- Collaborators
- Mead Johnson Nutrition
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previous LCPUFA Supplementation | – | –Children between the ages of 7 and 10 that were previously enrolled in a study of supplemented LCPUFA formula. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects who were originally enrolled as infants will be invited to participate in the longitudinal follow up study.
Key inclusion criteria (2 listed)
- Parents consent for children and children have the ability to assent
- Participation as an infant in the original study
Key exclusion criteria (1 listed)
- Those with orthodontic braces or extensive dental work that would make them unable to have an MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Event-Related Field (ERF) Amplitude and Latency
Time frame: Within 1 year post enrollment
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.
Regional gray and white matter brain volume
Time frame: Within 1 year post enrollment
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.
1 secondary outcome
Identify structural and metabolic mediators
Time frame: Within 1 year post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Derived from this study: PubMed 30311214Lepping 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Gustafson, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Kathleen Gustafson, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Related Field (ERF) Amplitude and Latency (time frame: Within 1 year post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02076048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.