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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 December 2015
Main ID:  NCT00892554
Date of registration: 01/05/2009
Prospective Registration: No
Primary sponsor: Emory University
Public title: The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU) PKU&DHA
Scientific title: The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
Date of first enrolment: June 2007
Target sample size: 33
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00892554
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  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Rani H. Singh, PhD, RD, LD
Address: 
Telephone:
Email:
Affiliation:  Emory University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Females

- Phenylketonuria

- Ages 12 years and older

- Able to complete neuropsychological testing

Exclusion Criteria:

- Pregnancy

- Currently taking DHA supplement



Age minimum: 12 Years
Age maximum: 50 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Phenylketonuria
Intervention(s)
Dietary Supplement: Docosahexaenoic Acid
Dietary Supplement: Corn/soy oil
Primary Outcome(s)
Cognitive processing speed [Time Frame: 0 months, 4.5 months]
Executive function [Time Frame: 0 months, 4.5 months]
Secondary Outcome(s)
Plasma and red blood cell DHA concentrations [Time Frame: 0 months, 4.5 months]
Secondary ID(s)
IRB00002447
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Atlanta Clinical and Translational Science Institute
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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