The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
PKU&DHA
The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 11, 2015
December 1, 2015
2.6 years
May 1, 2009
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cognitive processing speed
0 months, 4.5 months
Executive function
0 months, 4.5 months
Secondary Outcomes (1)
Plasma and red blood cell DHA concentrations
0 months, 4.5 months
Study Arms (2)
DHA supplementation
EXPERIMENTALcorn/soy capsule, no DHA
PLACEBO COMPARATORInterventions
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Eligibility Criteria
You may qualify if:
- Females
- Phenylketonuria
- Ages 12 years and older
- Able to complete neuropsychological testing
You may not qualify if:
- Pregnancy
- Currently taking DHA supplement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 22000478DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rani H. Singh, PhD, RD, LD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 1, 2009
First Posted
May 4, 2009
Study Start
June 1, 2007
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 11, 2015
Record last verified: 2015-12