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OpenTrials
Completed

NCT Number: NCT00892554

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

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.

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Key information

Conditions

Phenylketonuria Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Phenylketonurias

Age range

12 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Currently taking DHA supplement

Treatment and study plan

Docosahexaenoic acid

Dietary Supplement

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

Other names: DHASCO-S

Corn/soy oil

Dietary Supplement

Capsules taken once daily

Primary outcomes

  1. Cognitive processing speed

    Time frame: 0 months, 4.5 months

  2. Executive function

    Time frame: 0 months, 4.5 months

Secondary outcomes

  1. Plasma and red blood cell DHA concentrations

    Time frame: 0 months, 4.5 months

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Atlanta Clinical and Translational Science Institute

Registry information

Official study title

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

Acronym: PKU&DHA

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 4, 2009
Registry last updated
Dec 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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