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Trial record 9 of 53 for:    "Phenylketonuria"
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The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU) (PKU&DHA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Atlanta Clinical and Translational Science Institute
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00892554
First received: May 1, 2009
Last updated: November 14, 2009
Last verified: November 2009
History of Changes
  Purpose

The purpose of this study is to determine if taking supplemental DHA improves measures of processing speed and executive function in teen and adult women with PKU.


Condition Intervention
Phenylketonuria
 Dietary Supplement: Docosahexaenoic Acid
Dietary Supplement: Corn/soy oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Cognitive processing speed [ Time Frame: 0 months, 4.5 months ] [ Designated as safety issue: No ]
  • Executive function [ Time Frame: 0 months, 4.5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma and red blood cell DHA concentrations [ Time Frame: 0 months, 4.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: June 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: Docosahexaenoic Acid
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Other Name: DHASCO-S
Placebo Comparator: 2 Dietary Supplement: Corn/soy oil
Capsules taken once daily

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females
  • Phenylketonuria
  • Ages 12 years and older
  • Able to complete neuropsychological testing

Exclusion Criteria:

  • Pregnancy
  • Currently taking DHA supplement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892554

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Atlanta Clinical and Translational Science Institute
Investigators
Principal Investigator: Rani H. Singh, PhD, RD, LD Emory University
  More Information

Additional Information:
PKU & DHA Study Website  This link exits the ClinicalTrials.gov site

No publications provided by Emory University

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

Responsible Party: Rani H. Singh, PhD, RD, LD, Emory University
ClinicalTrials.gov Identifier: NCT00892554     History of Changes
Other Study ID Numbers: 7014
Study First Received: May 1, 2009
Last Updated: November 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Phenylketonurias
Docosahexaenoic Acids
Neuropsychological Tests
 Female
Adolescent
Adult

Additional relevant MeSH terms:
Phenylketonurias
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013