NCT00662142

Brief Summary

The goal of this study is to determine if 8-week dietary treatment with the omega-3 fatty acid docosahexaenoic acid (DHA) improves attention performance and associated cortical activity and metabolism in 8 - 10 year old males that were not breast-fed during infancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

April 16, 2008

Last Update Submit

May 15, 2013

Conditions

HealthyAttention

Keywords

DHAfMRI

Outcome Measures

Primary Outcomes (1)

  • performance on sustained attention task (CPT-IP)

    8 weeks

Secondary Outcomes (2)

  • fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP)

    8 weeks

  • NAA concentrations

    8 weeks

Study Arms (1)

1

EXPERIMENTAL

DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio

Dietary Supplement: docosahexaenoic acid

Interventions

docosahexaenoic acidDIETARY_SUPPLEMENT

DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio

Also known as: DHA
1

Eligibility Criteria

Age8 Years - 10 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male subjects between the ages of 8 - 10 years.
  • Not breast-fed during infancy
  • Right hand dominant
  • Attending school at appropriate grade level
  • Normal body-mass index (BMI)
  • Ability and willingness to provide assent and informed, written consent from at least one biological parent.
  • Present with biological parent
  • No current general medical or psychiatric illness.
  • Medication free.
  • Normal intelligence as assessed by the Kaufman Brief Intelligence Test.
  • Willingness to maintain current dietary habits.

You may not qualify if:

  • Inability or unwillingness to provide consent.
  • Antecedent or concurrent serious medical illness.
  • A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia)
  • Patients who have received any psychoactive medications, current and lifetime.
  • Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
  • History of seizures, excluding febrile seizures in childhood.
  • Patients requiring treatment with any drug which might obscure the action of study the study treatment.
  • Less than normal intelligence.
  • Pacemaker
  • Cerebral aneurysm clip
  • Cochlear implant
  • Metal fragments lodged within the eye
  • Claustrophobia
  • Necessity of sedation (no sedation will be given).
  • History of loss of consciousness \> 10 minutes in duration
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

  • McNamara RK, Able J, Jandacek R, Rider T, Tso P, Eliassen JC, Alfieri D, Weber W, Jarvis K, DelBello MP, Strakowski SM, Adler CM. Docosahexaenoic acid supplementation increases prefrontal cortex activation during sustained attention in healthy boys: a placebo-controlled, dose-ranging, functional magnetic resonance imaging study. Am J Clin Nutr. 2010 Apr;91(4):1060-7. doi: 10.3945/ajcn.2009.28549. Epub 2010 Feb 3.

    PMID: 20130094DERIVED

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Robert McNamara, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

January 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

US(1)