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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892554

Acronym

PKU&DHA

Enrollment

Registered

2009-05-04

Start date

2007-06-30

Completion date

2010-01-31

Last updated

2015-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phenylketonuria

Keywords

Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult

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.

Interventions

DIETARY_SUPPLEMENTDocosahexaenoic Acid

Capsules providing 10 mg DHA/kg body weight/day taken once daily

DIETARY_SUPPLEMENTCorn/soy oil

Capsules taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

12 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy * Currently taking DHA supplement

Design outcomes

Primary

Measure	Time frame
Cognitive processing speed	0 months, 4.5 months
Executive function	0 months, 4.5 months

Secondary

Measure	Time frame
Plasma and red blood cell DHA concentrations	0 months, 4.5 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026