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OpenTrials
Completed

NCT Number: NCT00662142

Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

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.

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Key information

Conditions

Age range

8 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Adopted

Treatment and study plan

Docosahexaenoic acid

Dietary Supplement

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

Other names: DHA

Primary outcomes

  1. performance on sustained attention task (CPT-IP)

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

  2. NAA concentrations

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 21, 2008
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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