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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01563913 |
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Date of registration:
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16/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
RLID-PD |
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Scientific title:
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Reducing Dyskinesia in Parkinson Disease With Omega-3 Fatty Acids |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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33 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01563913 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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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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Kathryn Anne Chung, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Portland Health Care System, Portland, OR |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with Parkinsons disease
- No levodopa (Sinemet) treatment or prior exposure to levodopa
Exclusion Criteria:
- Prior exposure to levodopa
- Unable to stand for 1 minute without aid
- Sensory deficits on feet
- Significant cognitive impairment
- Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone,
tetrabenazine, metoclopramide, dronabinol)
- Current fish oil or lutein supplementation
- Allergy to soy
Age minimum:
21 Years
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Docosahexaenoic Acid (DHA)
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Drug: Placebo
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Primary Outcome(s)
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Efficacy of DHA - Change in Blood ng/dL Levels
[Time Frame: baseline and 1.5 years]
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Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)
[Time Frame: Year 1]
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Secondary Outcome(s)
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Forceplate Measured Dyskinesia
[Time Frame: baseline and 1.5 years]
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Secondary ID(s)
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2907
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CLIN-006-11S
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8012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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