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NCT04088240 · ClinicalTrials.gov registry record · NA
Effects of Omega-3 Docosapentaenoic Acid on Lipids and Other Risk Factors for Cardiovascular Disease
A NA study, sponsored by University of Arizona.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT04088240 is a NA study that was terminated before completion, run by University of Arizona. The registered enrollment target is 5 participants.
The verdict
NCT04088240, a NA study, was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Elevated plasma triglycerides (TG) are due to an excess of TG-rich lipoproteins of several different types, most commonly of very-low-density lipoproteins (VLDL), but also intermediate-density lipoproteins (IDL, or VLDL remnants), chylomicrons, and/or chylomicron remnants. Epidemiologic evidence that a moderate elevation in TG is often associated with increased atherosclerotic cardiovascular disease (ASCVD) risk, and more recent evidence from Mendelian randomization studies has shown that elevated TG associated with genetic variants may be a causal factor for ASCVD and possibly for premature all-cause mortality.\[1-6\] Fasting plasma TG concentrations may be categorized as: normal (\< 150 mg/dL ), borderline (150-199 mg/dL), high TG (HTG, 200-499 mg/dL), and very high TG (VHTG, ≥ 500 mg/dL).\[7, 8\] Risk of acute pancreatitis is increased in VHTG patients, especially those with TG ≥ 1000 mg/dL.\[9\] For VHTG, the primary goal of therapy is to reduce TG to \< 500 mg/dL,\[10\] whereas there is no specific treatment goal for HTG nor prescription indication. However, the omega-3 fatty acids, EPA and DHA have well-established efficacy in reducing TG in the range of 150-500 when administered at doses of \> or = 3 g/d EPA+DHA (reviewed in Skulas-Ray et al. in press). Importantly, administration of omega-3 fatty acids to people with TG in this range lead to a 25% reduction in major adverse cardiovascular endpoints in the recently completed "Reduction of Cardiovascular Events with EPA Intervention Trial" (REDUCE-IT).\[11\] The results of REDUCE-IT provide compelling evidence for the use 3 g/d omega-3 fatty acid supplementation to reduce cardiovascular risk among patients with TG 150-500 mg/dL. The concentrated EPA supplement used in REDUCE-IT is just one of three long chain n-3 omega-3 fatty acids that influence lipids and lipoproteins and other aspects of cardiovascular risk. Most research has focused on the evaluation of EPA and DHA, which are the two predominant n-3 FA
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT DPA enriched n-3
- DIETARY_SUPPLEMENT n-3 control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2021-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04088240
The ClinicalTrials.gov registry entry for NCT04088240 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04088240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04088240 about?
NCT04088240 is a clinical study titled "Effects of Omega-3 Docosapentaenoic Acid on Lipids and Other Risk Factors for Cardiovascular Disease". Elevated plasma triglycerides (TG) are due to an excess of TG-rich lipoproteins of several different types, most commonly of very-low-density lipoproteins (VLDL), but also intermediate-density lipoproteins (IDL, or VLDL remnants), chylomicrons, and/or chylomicron remnants. Epidemiologic evidence tha...
What is the current status of trial NCT04088240?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2019-09-04. Estimated completion is 2021-01-31.
What interventions are being tested in trial NCT04088240?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), DPA enriched n-3 (DIETARY_SUPPLEMENT), n-3 control (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04088240?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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