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.
Atlanta Clinical and Translational Science Institute
Information provided by (Responsible Party):
Rani Singh, Emory University Identifier:
First received: May 1, 2009
Last updated: December 9, 2015
Last verified: December 2015
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
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


Ages Eligible for Study:   12 Years to 50 Years
Genders 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
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Please refer to this study by its identifier: NCT00892554

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rani Singh, Professor, Emory University Identifier: NCT00892554     History of Changes
Other Study ID Numbers: IRB00002447 
Study First Received: May 1, 2009
Last Updated: December 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Docosahexaenoic Acids
Neuropsychological Tests

Additional relevant MeSH terms:
Amino Acid Metabolism, Inborn Errors
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Central Nervous System Diseases
Genetic Diseases, Inborn
Metabolic Diseases
Metabolism, Inborn Errors
Nervous System Diseases processed this record on May 26, 2016