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

This study has been completed.
Sponsor:
Collaborator:
Atlanta Clinical and Translational Science Institute
Information provided by (Responsible Party):
Dawn Laney, MS, CCRC, Emory University
ClinicalTrials.gov Identifier:
NCT00892554
First received: May 1, 2009
Last updated: December 16, 2013
Last verified: December 2013
  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:


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 ]

Enrollment: 33
Study Start Date: June 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHA supplementation Dietary Supplement: Docosahexaenoic Acid
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Other Name: DHASCO-S
Placebo Comparator: corn/soy capsule, no DHA 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dawn Laney, MS, CCRC, Instructor, Emory University
ClinicalTrials.gov Identifier: NCT00892554     History of Changes
Other Study ID Numbers: IRB00002447
Study First Received: May 1, 2009
Last Updated: December 16, 2013
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 October 16, 2014