PhenylketonuriaPKU&DHANCT00892554
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)
A study testing Docosahexaenoic Acid and Corn/soy oil in people with Phenylketonuria, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years, women only
- Conditions the study is for
- Phenylketonuria
- What is being tested?
- Docosahexaenoic Acid and Corn/soy oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Females
- Phenylketonuria
- Ages 12 years and older
- Able to complete neuropsychological testing
Who cannot join
- Pregnancy
- Currently taking DHA supplement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
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.
- Conditions
- Phenylketonuria
- Being tested
- Docosahexaenoic Acid, Corn/soy oil
- Keywords
- Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult
- Medical subject headings
- Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic AcidDietary supplement
Also called DHASCO-S
Capsules providing 10 mg DHA/kg body weight/day taken once daily
Corn/soy oilDietary supplement
Capsules taken once daily
| Study group | Role | What they receive |
|---|---|---|
| DHA supplementation | Experimental | Not described Receives: Dietary Supplement: Docosahexaenoic Acid |
| corn/soy capsule, no DHA | Placebo comparator | Not described Receives: Dietary Supplement: Corn/soy oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive processing speed
Measured: 0 months, 4.5 months
Executive function
Measured: 0 months, 4.5 months
Secondary outcomes (1)
Plasma and red blood cell DHA concentrations
Measured: 0 months, 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startJun 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PhenylketonuriaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Responsible party
- Principal investigator, Rani Singh, Emory University
- Investigators
- Rani H. Singh, PhD, RD, LD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892554
- Sponsor's protocol ID
- IRB00002447
- Acronym
- PKU&DHA
- Status last verified
- Dec 2015
- First submitted
- 1 May 2009
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22000478
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Docosahexaenoic Acid on Neuropsychological Status in Females With Phenylketonuria
- ClinicalTrials.gov ID
- NCT00892554
- Acronym / sponsor ID
- PKU&DHA / IRB00002447
- Conditions
- Phenylketonuria
- Keywords
- Phenylketonurias, Docosahexaenoic Acids, Neuropsychological Tests, Female, Adolescent, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Atlanta Clinical and Translational Science Institute
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA supplementation | Experimental | Dietary Supplement: Docosahexaenoic Acid |
| corn/soy capsule, no DHA | Placebo comparator | Dietary Supplement: Corn/soy oil |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Females
- Phenylketonuria
- Ages 12 years and older
- Able to complete neuropsychological testing
Key exclusion criteria (2 listed)
- Pregnancy
- Currently taking DHA supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic AcidAlso: DHASCO-SCapsules providing 10 mg DHA/kg body weight/day taken once daily | Dietary supplement | DHA supplementation |
| Corn/soy oilCapsules taken once daily | Dietary supplement | corn/soy capsule, no DHA |
Primary outcome
Cognitive processing speed
Time frame: 0 months, 4.5 months
Executive function
Time frame: 0 months, 4.5 months
1 secondary outcome
Plasma and red blood cell DHA concentrations
Time frame: 0 months, 4.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 22000478Yi 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.
- PKU \& DHA Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rani H. Singh, PhD, RD, LD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docosahexaenoic Acid and Corn/soy oil in people with Phenylketonuria, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive processing speed (time frame: 0 months, 4.5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.