- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03444662
The Combination Effect of Citicoline and Omega-3
September 9, 2019 updated by: Kyowa Hakko Bio Co., Ltd.
The Combination of Citicoline and Omega-3 on Attention in Healthy Subjects
The goal of this study is to determine the effects of Citicoline plus Omega-3 or Omega-3 alone versus placebo on attention in non-demented healthy older adults.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is a randomized, double-blind, placebo-controlled trial.
The investigators hypothesize that supplementation of Citicoline plus Omega-3 will improve attention in healthy adults age 55 years and older, compared to placebo.
The study is designed as 3-arm, parallel group study comparing placebo, Omega-3 only, and Citicoline plus Omega-3.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 55 years or older
- If female, must be post-menopausal
- Non-demented
- Not depressed
- General health status that will not interfere with the participant's ability to complete the study
- No history of neurological disorder
- Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
- Sufficient English language skills to complete all testing
Exclusion Criteria:
- Alzheimer's, Dementia or other neurological disease
- Fish intake of 6 ounce serving once a week 3 months prior to enrollment; Omega-3 supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 3 months prior to enrollment.
- Citicoline supplementation 3 months prior to enrollment
Prescriptions medications:
- Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven), Factor Xa inhibitors: rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis); Low molecular weight heparins: dalteparin (fragmin), enoxaparin (lovenox)
- Dementia medications (e.g. anticholinesterase inhibitors, memantine)
- Diagnosis of Adult Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) and/or taking stimulants (e.g. dextroamphetamine sulfate, methylphenidate HCL, dextroamphetamine Sulf-Saccharate)
- Body Mass Index > 30
- Enrollment in another treatment study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo supplement
|
Cellulose and Sunflower oil
Other Names:
|
Experimental: Cognizin and Omega-3
Intervention: Dietary Supplement: Citicoline and Omega-3 supplement
|
Citicoline and Omega-3
Other Names:
|
Experimental: Omega-3
Intervention: Dietary Supplement: Omega-3 supplement
|
Cellulose and Omega-3
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accuracy (percent correct) on an attention task (Conners continuous performance test3)
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scores of Neuropsychological test battery from the Uniform Data Set
Time Frame: 16 weeks
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with treatment-related adverse events as monitored by recording a comprehensive metabolic panel, complete blood count and prothrombin time-international normalized ratio
Time Frame: 16 weeks
|
16 weeks
|
Plasma fatty acid levels
Time Frame: 16 weeks
|
16 weeks
|
Apolipoprotein E genotype
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2018
Primary Completion (Actual)
September 3, 2019
Study Completion (Actual)
September 3, 2019
Study Registration Dates
First Submitted
February 14, 2018
First Submitted That Met QC Criteria
February 19, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16518
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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