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

Primary Purpose

Phenylketonuria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Docosahexaenoic Acid
Corn/soy oil
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phenylketonuria focused on measuring Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult

Eligibility Criteria

12 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Currently taking DHA supplement

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHA supplementation

corn/soy capsule, no DHA

Arm Description

Outcomes

Primary Outcome Measures

Cognitive processing speed
Executive function

Secondary Outcome Measures

Plasma and red blood cell DHA concentrations

Full Information

First Posted
May 1, 2009
Last Updated
December 9, 2015
Sponsor
Emory University
Collaborators
Atlanta Clinical and Translational Science Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00892554
Brief Title
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
Acronym
PKU&DHA
Official Title
The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Atlanta Clinical and Translational Science Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phenylketonuria
Keywords
Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA supplementation
Arm Type
Experimental
Arm Title
corn/soy capsule, no DHA
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic Acid
Other Intervention Name(s)
DHASCO-S
Intervention Description
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn/soy oil
Intervention Description
Capsules taken once daily
Primary Outcome Measure Information:
Title
Cognitive processing speed
Time Frame
0 months, 4.5 months
Title
Executive function
Time Frame
0 months, 4.5 months
Secondary Outcome Measure Information:
Title
Plasma and red blood cell DHA concentrations
Time Frame
0 months, 4.5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females Phenylketonuria Ages 12 years and older Able to complete neuropsychological testing Exclusion Criteria: Pregnancy Currently taking DHA supplement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rani H. Singh, PhD, RD, LD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22000478
Citation
Yi SH, Kable JA, Evatt ML, Singh RH. A randomized, placebo-controlled, double-blind trial of supplemental docosahexaenoic acid on cognitive processing speed and executive function in females of reproductive age with phenylketonuria: A pilot study. Prostaglandins Leukot Essent Fatty Acids. 2011 Dec;85(6):317-27. doi: 10.1016/j.plefa.2011.09.004. Epub 2011 Oct 14.
Results Reference
derived
Links:
URL
http://genetics.emory.edu/NUTRITION/pku_dha_study/
Description
PKU & DHA Study Website

Learn more about this trial

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

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