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NCT00892554 Clinical Trial

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

Phenylketonuria Clinical Trial

— PKU&DHA  

Official title:
The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00892554
Other study ID # IRB00002447
Secondary ID
Status Completed
Phase N/A
First received May 1, 2009
Last updated December 9, 2015
Start date June 2007
Est. completion date January 2010

Study information
Verified date December 2015
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Female
Age group 12 Years to 50 Years
Eligibility Inclusion Criteria:

- Females

- Phenylketonuria

- Ages 12 years and older

- Able to complete neuropsychological testing

Exclusion Criteria:

- Pregnancy

- Currently taking DHA supplement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Docosahexaenoic Acid
Capsules providing 10 mg DHA/kg body weight/day taken once daily
• Corn/soy oil
Capsules taken once daily

Locations
Country Name City State
United States Emory University Atlanta Georgia

Sponsors (2)
Lead Sponsor Collaborator
Emory University Atlanta Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cognitive processing speed 0 months, 4.5 months No
Primary Executive function 0 months, 4.5 months No
Secondary Plasma and red blood cell DHA concentrations 0 months, 4.5 months No
See also
  Status Clinical Trial Phase
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Completed NCT00925054 - Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU Phase 2
Completed NCT00778206 - PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
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Terminated NCT01465100 - Liver Cell Transplant for Phenylketonuria Phase 1/Phase 2
Completed NCT01732471 - Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria Phase 3
Completed NCT04879277 - Study of Low-grade Systemic Inflammation in Adult Patients With Phenylketonuria N/A
Completed NCT02176603 - Observational Study of Endothelial Dysfunction in Phenylketonuria N/A
Completed NCT01819727 - An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165 Phase 3
Completed NCT01869972 - Biological Variation of Phenylalanine in Patients With Hyperphenylalaninemia N/A
Terminated NCT01904708 - Moderate Intensity Exercise and Phenylketonuria N/A

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