Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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21 December 2015 |
Main ID: |
NCT00892554 |
Date of registration:
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01/05/2009 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
PKU&DHA |
Scientific title:
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The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria |
Date of first enrolment:
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June 2007 |
Target sample size:
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33 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00892554 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Rani H. Singh, PhD, RD, LD |
Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Females
- Phenylketonuria
- Ages 12 years and older
- Able to complete neuropsychological testing
Exclusion Criteria:
- Pregnancy
- Currently taking DHA supplement
Age minimum:
12 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Phenylketonuria
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Intervention(s)
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Dietary Supplement: Docosahexaenoic Acid
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Dietary Supplement: Corn/soy oil
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Primary Outcome(s)
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Cognitive processing speed
[Time Frame: 0 months, 4.5 months]
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Executive function
[Time Frame: 0 months, 4.5 months]
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Secondary Outcome(s)
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Plasma and red blood cell DHA concentrations
[Time Frame: 0 months, 4.5 months]
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Secondary ID(s)
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IRB00002447
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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