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PKU&DHA: The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT00892554
Collaborator
Atlanta Clinical and Translational Science Institute (Other)
33
Enrollment
1
Location
2
Arms
31
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Dietary Supplement: Docosahexaenoic Acid
  • Dietary Supplement: Corn/soy oil
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: DHA supplementation

Dietary Supplement: Docosahexaenoic Acid
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Other Names:
  • DHASCO-S

    		•
    Placebo Comparator: corn/soy capsule, no DHA

    Dietary Supplement: Corn/soy oil
    Capsules taken once daily

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive processing speed [0 months, 4.5 months]

    2. Executive function [0 months, 4.5 months]

    Secondary Outcome Measures

    1. Plasma and red blood cell DHA concentrations [0 months, 4.5 months]

    Eligibility Criteria

    Criteria

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

    • Females

    • Phenylketonuria

    • Ages 12 years and older

    • Able to complete neuropsychological testing

    Exclusion Criteria:

    • Pregnancy

    • Currently taking DHA supplement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Rani Singh, Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT00892554
    Other Study ID Numbers:
    • IRB00002447
    First Posted:
    May 4, 2009
    Last Update Posted:
    Dec 11, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Rani Singh, Professor, Emory University
    Phenylketonurias
    Docosahexaenoic Acids
    Neuropsychological Tests
    Female
    Adolescent
    Adult
    Additional relevant MeSH terms:
    Phenylketonurias

    Study Results

    No Results Posted as of Dec 11, 2015