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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00662142
First received: April 16, 2008
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
Attention
 Dietary Supplement: docosahexaenoic acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of 8-Week Dietary DHA Supplementation on Cerebral Blood Flow and Metabolic Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • performance on sustained attention task (CPT-IP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fMRI activation of prefrontal and frontal cortical regions during performance of an attention task (CPT-IP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • NAA concentrations [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
DHA 400 mg/day (200mg twice daily), vs DHA 1200 mg/day (400 mg three times daily), vs placebo; 1:1:1 ratio
Other Name: DHA

  Eligibility

Ages Eligible for Study:   8 Years to 10 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability or unwillingness to provide consent.
  2. Antecedent or concurrent serious medical illness.
  3. A lifetime history of any significant axis I psychiatric disorder ( i.e. bipolar disorder, schizophrenia)
  4. Patients who have received any psychoactive medications, current and lifetime.
  5. Clinically unstable medical disease, including cardiovascular, hepatic insufficiency, severe renal impairment, gastrointestinal, pulmonary, metabolic, endocrine, obesity or other systemic disease.
  6. History of seizures, excluding febrile seizures in childhood.
  7. Patients requiring treatment with any drug which might obscure the action of study the study treatment.
  8. Less than normal intelligence.
  9. Pacemaker
  10. Cerebral aneurysm clip
  11. Cochlear implant
  12. Metal fragments lodged within the eye
  13. Claustrophobia
  14. Necessity of sedation (no sedation will be given).
  15. History of loss of consciousness > 10 minutes in duration
  16. Adopted
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662142

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Robert McNamara, PhD University of Cincinnati
  More Information

No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00662142     History of Changes
Other Study ID Numbers: 05-12-13-03 (MARTEK)
Study First Received: April 16, 2008
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
DHA
fMRI

ClinicalTrials.gov processed this record on May 21, 2013