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

Not Applicable

Completed

• Conditions: Phenylketonuria
• Interventions: Dietary Supplement: Docosahexaenoic Acid; Dietary Supplement: Corn/soy oil

• Registration Number: NCT00892554
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Females
• Phenylketonuria
• Ages 12 years and older
• Able to complete neuropsychological testing

Read More

Exclusion Criteria

• Pregnancy
• Currently taking DHA supplement

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA supplementation	Docosahexaenoic Acid	-
corn/soy capsule, no DHA	Corn/soy oil	-

Primary Outcome Measures

Name	Time	Method
Executive function	0 months, 4.5 months
Cognitive processing speed	0 months, 4.5 months

Secondary Outcome Measures

Name	Time	Method
Plasma and red blood cell DHA concentrations	0 months, 4.5 months

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States