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

Emory University

Status: Completed

Conditions: Phenylketonuria

Treatments: Dietary Supplement: Corn/soy oil; Dietary Supplement: Docosahexaenoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00892554

IRB00002447

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Female

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy
• Currently taking DHA supplement

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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33 participants in 2 patient groups, including a placebo group

DHA supplementation

Experimental group

Treatment:

Dietary Supplement: Docosahexaenoic Acid

corn/soy capsule, no DHA

Placebo Comparator group

Treatment:

Dietary Supplement: Corn/soy oil