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Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
NCT00988585 · View on ClinicalTrials.gov ↗
Study Summary
The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will be randomized to one of four groups (30 in each group) and studied in both the fasting and post-prandial state.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT DHA
- DIETARY_SUPPLEMENT Olive Oil
- DIETARY_SUPPLEMENT EPA 600
- DIETARY_SUPPLEMENT EPA 1800
Study Locations (1)
Massachusetts
- Cardiovascular Research Associates — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988585
The ClinicalTrials.gov registry entry for NCT00988585 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiovascular Research Associates, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Disease appearing as the primary indexed condition, and to 4 interventions — of which DHA is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00988585 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00988585 about?
NCT00988585 is a clinical study titled "Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil". The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such a dietary supplement on the market. The goal of this study is to test this oil at doses of 600 mg and 1800 mg of EPA...
What is the current status of trial NCT00988585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2009-04. Estimated completion is 2009-12.
What conditions does trial NCT00988585 study?
This clinical trial studies the following conditions: Heart Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00988585?
The interventions under investigation include: DHA (DIETARY_SUPPLEMENT), Olive Oil (DIETARY_SUPPLEMENT), EPA 600 (DIETARY_SUPPLEMENT), EPA 1800 (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00988585?
This trial is sponsored by Cardiovascular Research Associates, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00988585 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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